# Genzyme Diagnostics P.E.I., Inc.

- Location (FDA's records): Charlottetown, Prin Ed Island, CA
- FDA decisions: 2 (2008–2009): 2 510(k) clearances
- Product codes: LDP (1), CIG (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (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
- Diagnostic Chemicals, Ltd.: 1 (https://510kreport.com/company/diagnostic-chemicals)

## Firms that cite its devices most
- Sekisui Diagnostics P.E.I., Inc.: 2 (https://510kreport.com/company/sekisui-diagnostics-pei)

## Its most-cited devices
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 (2009), cited by 2

## Recent decisions
- K081938: Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30 (May 1, 2009)
- K082210: Total Bilirubin L3K, Model 295-10 and 295-30 (Dec 16, 2008)

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