# Mrl Diagnostics

- Location (FDA's records): Cypress, CA
- FDA decisions: 7 (1994–2000): 7 510(k) clearances
- Product codes: LSR (2), MYF (1), LGC (1), LLM (1), LJN (1), MXJ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 17 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hillcrest Biologicals: 2 (https://510kreport.com/company/hillcrest-biologicals)

## Firms that cite its devices most
- Biokit, S.A.: 4 (https://510kreport.com/company/biokit)
- Focus Technologies, Inc.: 3 (https://510kreport.com/company/focus-technologies)
- DiaSorin, Inc.: 2 (https://510kreport.com/company/diasorin)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Zeus Scientific, Inc.: 2 (https://510kreport.com/company/zeus-scientific)
- Theranos, Inc.: 1 (https://510kreport.com/company/theranos)
- Gold Standard Diagnostics: 1 (https://510kreport.com/company/gold-standard-diagnostics)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G (2000), cited by 14
- K993724: HSV-2 Elisa Igg, Model EL0920G (2000), cited by 3

## Recent decisions
- K000238: HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G (Apr 14, 2000)
- K993754: HSV-1 Elisa Igg, Model EL0910G (Feb 9, 2000)
- K993724: HSV-2 Elisa Igg, Model EL0920G (Feb 1, 2000)
- K971006: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G) (Jun 1, 1998)
- K971007: Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M) (Jun 1, 1998)
- K946353: Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent Assay (Jul 21, 1995)
- K931520: Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody (Apr 26, 1994)

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