Immunostics, Inc.
Eatontown, NJ, US
IMMUNOSTICS, INC. appears in FDA device records in Eatontown, NJ. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 25 510(k) clearances for Immunostics, Inc. between 1984 and 2023. The busiest year on record is 2017, with 4. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1997 | 3 |
| 1999 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2017 | 4 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | MRG | Substantially Equivalent | |
| K182298 | hemochroma PLUS System | GKR | Substantially Equivalent | |
| K163465 | hemochroma PLUS System | GKR | Substantially Equivalent | |
| K163225 | AFIAS iFOB with AFIAS-50 | OOX | Substantially Equivalent | |
| K171484 | hema-screen SPECIFIC Gold | KHE | Substantially Equivalent | |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | KHE | Substantially Equivalent | |
| K102664 | HEMA SCREEN ER | KHE | Substantially Equivalent | |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | KHE | Substantially Equivalent | |
| K041728 | HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE | JHI | Substantially Equivalent | |
| K031490 | RUBELLACOL | LQN | Substantially Equivalent | |
| K992759 | COLON ALERT TEST | KHE | Substantially Equivalent | |
| K972457 | MONOCOL/LEX-IM TEST | KTN | Substantially Equivalent | |
| K972456 | RHEUMACOL RHEUMATOID FACTOR TEST | DHR | Substantially Equivalent | |
| K972606 | PREGNACOL PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K926569 | IMMUNO RA UNDILUTED | DHR | Substantially Equivalent | |
| K902360 | HEMA-SCREEN | KHE | Substantially Equivalent | |
| K894780 | IMMUNO/ASO | GTQ | Substantially Equivalent | |
| K883685 | IMMUNO/FEBRILE ANTIGENS | GNC | Substantially Equivalent | |
| K872910 | IMMUNO/SLE | DHC | Substantially Equivalent | |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | JHJ | Substantially Equivalent | |
| K854619 | DETECTACULT | KHE | Substantially Equivalent | |
| K853105 | IMMUNO-IM | KTN | Substantially Equivalent | |
| K842110 | SLIDE PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K834391 | IMMUNO-RA | DHR | Substantially Equivalent | |
| K834390 | IMMUNO-CRP | DCN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2244821 | 2244821 | IMMUNOSTICS, INC. | 38 Industrial Way E Ste 1, Eatontown, NJ 07724 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GTYAntigens, All Groups, Streptococcus Spp.
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- OOXAutomated Occult Blood Analyzer
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- GGMControl, Hemoglobin
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- LYRHelicobacter Pylori
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LQNLatex Agglutination Assay, Rubella
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- OHQMulti-Analyte Controls Unassayed
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- KHEReagent, Occult Blood
- JRERefractometer For Clinical Use
- GKRSystem, Hemoglobin, Automated
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- MRGSystem, Test, Vitamin D
- LJXTest, Urine Leukocyte
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0702-2024 | Detector H. Pylori, Catalog Number IHP-30 | Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain