# Scimedx Corp.

- Location (FDA's records): Denvill, NJ
- FDA decisions: 14 (1996–2001): 14 510(k) clearances
- Product codes: MOB (5), MVM (3), MST (2), JZO (1), MVJ (1), DBL (1), DHN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Hemagen Diagnostics, Inc.: 4 (https://510kreport.com/company/hemagen-diagnostics)
- Grifols USA, LLC: 1 (https://510kreport.com/company/grifols-usa)

## Its most-cited devices
- K954105: Eia Kit for the Detction of Anti-PR3 Antibodies (1996), cited by 2
- K954062: Eia Kit for the Detection of Anti-Mpo Antibodies (1996), cited by 2
- K010625: Eurospital EU-TTG Iga Umana (2001), cited by 1

## Recent decisions
- K011348: Phase II GBM Igg Antibody Eia Test (Jun 25, 2001)
- K011082: Tpo Igg Antibody Eia Test (Jun 6, 2001)
- K010625: Eurospital EU-TTG Iga Umana (Apr 24, 2001)
- K010287: Scimedx Phase II PR3 Igg Antibody Eia (Mar 16, 2001)
- K010289: Scimedx Phase II Mpo Igg Antibody Eia (Mar 7, 2001)
- K002189: Gliadin Igg Antibody Eia Detection System (Oct 19, 2000)
- K002169: Gliadin Iga Antibody Eia Detection System (Oct 19, 2000)
- K002107: Ifa Kit for the Detection of Endomysial Iga Anibodies Using Primate Umbilical Cord (Puc)-Ema/Puc Lga. (Aug 4, 2000)

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