Hemagen Diagnostics, Inc.
Baltimore, MD, US
HEMAGEN DIAGNOSTICS, INC. appears in FDA device records in Baltimore, MD. FDA records list 52 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 52FDA records hold 52 510(k) clearances for Hemagen Diagnostics, Inc. between 1986 and 2004. The busiest year on record is 1995, with 9. The most recent is 2004, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 9 |
| 1996 | 3 |
| 1997 | 7 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 5 |
| 2003 | 1 |
| 2004 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | CFR | Substantially Equivalent | |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | CDQ | Substantially Equivalent | |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | CIC | Substantially Equivalent | |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | JJY | Substantially Equivalent | |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | LBR | Substantially Equivalent | |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | MRR | Substantially Equivalent | |
| K022767 | RAICHEM LIPID CALIBRATOR | JIX | Substantially Equivalent | |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | DCK | Substantially Equivalent | |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | CJY | Substantially Equivalent | |
| K012668 | RAICHEM GLUCOSE UV REAGENT | CFR | Substantially Equivalent | |
| K012649 | RAICHEM BUN RATE REAGENT | CDQ | Substantially Equivalent | |
| K012250 | RAICHEM MULTI-ANALYTE CALIBRATOR | JIX | Substantially Equivalent | |
| K010864 | ANALYST PANELS + ANALYTICAL TEST ROTOR | KHS | Substantially Equivalent | |
| K011126 | RAICHEM CREATININE URINE STANDARD | JIT | Substantially Equivalent | |
| K003012 | RAICHEM PHOSPORUS REAGENT | CEO | Substantially Equivalent | |
| K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT | MSV | Substantially Equivalent | |
| K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT | MSV | Substantially Equivalent | |
| K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT | MSV | Substantially Equivalent | |
| K973824 | VIRGO PANCO KIT | MOB | Substantially Equivalent | |
| K973823 | PR 3 ANTIBODY KIT | MOB | Substantially Equivalent | |
| K973822 | VIRGO ANCA SCREEN KIT | MOB | Substantially Equivalent | |
| K972812 | RAICHEM PREALBUMIN SPIA | DDS | Substantially Equivalent | |
| K971909 | VIRGO AMA ELISA KIT | DBM | Substantially Equivalent | |
| K971039 | HEMAGEN ANTI CARDIOLIPIN SCREEN | MID | Substantially Equivalent | |
| K944438 | HEMAGEN CMV IGG KIT | LFZ | Substantially Equivalent | |
| K962276 | HEMAGEN ENA DSDNA KIT (EIA METHOD) | DHN | Substantially Equivalent | |
| K962836 | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) | DHR | Substantially Equivalent | |
| K960324 | HEMAGEN CRP 150 KIT (EIA METHOD) | DCK | Substantially Equivalent | |
| K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) | MIU | Substantially Equivalent | |
| K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K946123 | HEMAGEN ENA SM KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K944288 | HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) | DCK | Substantially Equivalent | |
| K941840 | HEMAGEN ACL IGA CALIBRATOR | MID | Substantially Equivalent | |
| K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K932373 | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 | MID | Substantially Equivalent | |
| K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K915272 | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) | LJM | Substantially Equivalent | |
| K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | LLL | Substantially Equivalent | |
| K910232 | HEMAGEN ENA SCREENING KIT | LLL | Substantially Equivalent | |
| K902139 | HEMAGEN ENA [JO-I] KIT | DHN | Substantially Equivalent | |
| K900617 | SERATEST ENA [SSA] KIT | LLL | Substantially Equivalent | |
| K894411 | SERATEST ENA [SCL-70] KIT | LKJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1181055 | 1181055 | HEMAGEN DIAGNOSTICS, INC. | 2900 LOCH RAVEN RD, Baltimore, MD 21218 US | 2026 | and 33 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- GMSAnti-Human Globulin, Fta-Abs Test
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)
- GLZAntigens, If, Toxoplasma Gondii
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GOKAntisera, Hai (Including Hai Control), Rubella
- GNPAntiserum, Cf, Epstein-Barr Virus
- GRAAntiserum, Fluorescent, Mumps Virus
- GREAntiserum, Fluorescent, Rubeola
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHMColorimetric Method, Lipoproteins
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- KHSEnzymatic, Carbon-Dioxide
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- KLSEnzyme Immunoassay, Theophylline
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi
- LLLExtractable Antinuclear Antibody, Antigen And Control
- PPMGeneral Purpose Reagent
- CFRHexokinase, Glucose
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- MIDSystem, Test, Anticardiolipin Immunological
- MRRSystem, Test, Low Density, Lipoprotein
- DHRSystem, Test, Rheumatoid Factor
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- MZETest, Donor, Cmv
- GGWTest, Time, Partial Thromboplastin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain