# Mardx Diagnostics, Inc.

- Location (FDA's records): Scotch Plains, NJ
- FDA decisions: 8 (1989–1997): 8 510(k) clearances
- Product codes: LSR (6), LRM (1), LLL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (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
- Gold Standard Diagnostics: 6 (https://510kreport.com/company/gold-standard-diagnostics)
- Boston Biomedica, Inc.: 2 (https://510kreport.com/company/boston-biomedica)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Trinity Biotech, Plc: 2 (https://510kreport.com/company/trinity-biotech)
- Bioarray Solutions, Ltd.: 1 (https://510kreport.com/company/bioarray-solutions)

## Its most-cited devices
- K894293: Mardx Lyme Disease Eia (Igm) Test System (1989), cited by 3
- K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System (1996), cited by 3
- K950829: Mardx Lyme Disease (Igg) Marblot Strip Test System (1996), cited by 3
- K894224: Mardx Lyme Disease Eia (Igg) Test System (1989), cited by 3
- K964787: Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System (1997), cited by 1

## Recent decisions
- K964787: Mardx Ena Igg Immunostripe Test System / Mardx Ena Igg Marstripe Test System (Apr 8, 1997)
- K951709: Mardx Lyme Disease (Igm) Marblot Strip Test System (Jun 7, 1996)
- K950829: Mardx Lyme Disease (Igg) Marblot Strip Test System (Jun 5, 1996)
- K960182: Dsdna Immunoglobulin Eia Test System (Mar 20, 1996)
- K894293: Mardx Lyme Disease Eia (Igm) Test System (Aug 21, 1989)
- K894224: Mardx Lyme Disease Eia (Igg) Test System (Aug 21, 1989)
- K892206: Mardx Llyme Disease Eia (Igg & Igm) Test System (Aug 15, 1989)
- K890053: Mardx Lyme Disease Igg Ifa Test System (Apr 18, 1989)

Source page: https://510kreport.com/company/mardx-diagnostics