# Genzyme Diagnostics

- Location (FDA's records): San Carlos, CA
- FDA decisions: 5 (1996–2005): 5 510(k) clearances
- Product codes: JHI (3), MHI (1), KTN (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medix Biotech, Inc.: 2 (https://510kreport.com/company/medix-biotech)

## Firms that cite its devices most
- Remel Co.: 3 (https://510kreport.com/company/remel)

## Its most-cited devices
- K983399: Giardia/Cryptosporidium Combo Rapid Assay (1999), cited by 3

## Recent decisions
- K043385: Osom HCG Combo Test (Apr 12, 2005)
- K983399: Giardia/Cryptosporidium Combo Rapid Assay (Jan 11, 1999)
- K963425: Genzyme Diagnostics Contrast Mono (Feb 25, 1997)
- K964155: Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test (Nov 25, 1996)
- K964156: Contrast Strip HCG (Nov 25, 1996)

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