# Immunostics Inc.,

- Location (FDA's records): Ocean, NJ
- FDA decisions: 25 (1984–2023): 25 510(k) clearances
- Names in FDA's records: Immunostics Inc., (14); Immunostics Co., Inc. (11)
- Product codes: KHE (7), JHJ (3), DHR (3), GKR (2), KTN (2), GNC (1), LQN (1), MRG (1), JHI (1), DHC (1), GTQ (1), DCN (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hemocue, Inc.: 2 (https://510kreport.com/company/hemocue)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Boditech Med, Inc.: 1 (https://510kreport.com/company/boditech-med)

## Its most-cited devices
- K102664: Hema Screen ER (2011), cited by 1
- K060463: Hema Screen Specific Ifobt (2006), cited by 1

## Recent decisions
- K221817: ALFIS Vitamin D, ALFIS-3 Analyzer (Sep 22, 2023)
- K182298: hemochroma PLUS System (Nov 16, 2018)
- K163465: hemochroma PLUS System (Sep 8, 2017)
- K163225: AFIAS iFOB with AFIAS-50 (Aug 8, 2017)
- K171484: hema-screen SPECIFIC Gold (Jun 14, 2017)
- K163554: hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (Jan 17, 2017)
- K102664: Hema Screen ER (Jan 28, 2011)
- K060463: Hema Screen Specific Ifobt (Jun 6, 2006)

Source page: https://510kreport.com/company/immunostics