Hycor Biomedical
Garden Grove, CA, US
HYCOR BIOMEDICAL appears in FDA device records in Garden Grove, CA. FDA records list 66 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 66FDA records hold 66 510(k) clearances for Hycor Biomedical between 1989 and 2026. The busiest year on record is 1997, with 10. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 4 |
| 1990 | 5 |
| 1991 | 1 |
| 1992 | 7 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 8 |
| 1996 | 9 |
| 1997 | 10 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 2 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | DHB | Substantially Equivalent | |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | DHB | Substantially Equivalent | |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | DHB | Substantially Equivalent | |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | DHB | Substantially Equivalent | |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | DHB | Substantially Equivalent | |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | DHB | Substantially Equivalent | |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | DHB | Substantially Equivalent | |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | DHB | Substantially Equivalent | |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | DHB | Substantially Equivalent | |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | DHB | Substantially Equivalent | |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | DHB | Substantially Equivalent | |
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | DHB | Substantially Equivalent | |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | DHB | Substantially Equivalent | |
| K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA | MVM | Substantially Equivalent | |
| K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA | MVM | Substantially Equivalent | |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | MID | Substantially Equivalent | |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | MSV | Substantially Equivalent | |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | MSV | Substantially Equivalent | |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | MSV | Substantially Equivalent | |
| K965094 | HYCOR ALLERGEN DISC | DHB | Substantially Equivalent | |
| K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | LRM | Substantially Equivalent | |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | DHR | Substantially Equivalent | |
| K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY | LLL | Substantially Equivalent | |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | DBM | Substantially Equivalent | |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | JNL | Substantially Equivalent | |
| K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE | LJM | Substantially Equivalent | |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | JNL | Substantially Equivalent | |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | LKO | Substantially Equivalent | |
| K954896 | HYTEC AUTOIMMUNE KITS (SM) | LKP | Substantially Equivalent | |
| K954895 | HYTEC AUTOIMMUNE KIT (JO-1) | LLL | Substantially Equivalent | |
| K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) | LLL | Substantially Equivalent | |
| K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) | LRM | Substantially Equivalent | |
| K954892 | HYTEC AUTOMIMMUNE KIT (RF) | DHR | Substantially Equivalent | |
| K954891 | HYTEC AUTOIMMUNE KITS (SS-B) | LKJ | Substantially Equivalent | |
| K954890 | HYTEC AUTOMMUNE KIT (ENA) | LLL | Substantially Equivalent | |
| K954392 | HYTEC AUTOIMMUNE KIT (SS-A) | LKJ | Substantially Equivalent | |
| K945884 | SPECIFIC IGE ULTRA-EIA | DHB | Substantially Equivalent | |
| K945748 | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY | DHB | Substantially Equivalent | |
| K941278 | HY-TEC AUTOMATED EIA SYSTEM | DHB | Substantially Equivalent | |
| K941057 | SPECIFIC IGE EIA-ULTRA ASSAY | DHB | Substantially Equivalent | |
| K942853 | KOVA LIQUA-TROL | JJW | Substantially Equivalent | |
| K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY | DGC | Substantially Equivalent | |
| K925425 | SPECIFIC IGE EIA-TURBO ASSAY | DHB | Substantially Equivalent | |
| K924044 | VENTREX ALLERGEN DISC | DHB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2016473 | 1000125787 | HYCOR BIOMEDICAL | 7272 Chapman Ave, GARDEN GROVE, CA 92841 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)
- DKBCalibrators, Drug Mixture
- DIFDrug Mixture Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LYRHelicobacter Pylori
- DGCIge, Antigen, Antiserum, Control
- JNLImmunochemical, Thyroglobulin Autoantibody
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- MVUReagents, Specific, Analyte
- MIDSystem, Test, Anticardiolipin Immunological
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
- DHRSystem, Test, Rheumatoid Factor
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0224-2020 | HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114. | Some of the Stop Solution bottles, a caustic solution, have been reported to leak. | Class II | Open, Classified | |
| Z-2200-2019 | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08. | Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid. | Class II | Open, Classified | |
| Z-2134-2019 | AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only. | Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor. | Class II | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain