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

- Location (FDA's records): Charlottetown,, CA
- FDA decisions: 6 (2011–2022): 6 510(k) clearances
- Product codes: LDP (2), JGJ (1), JIT (1), PDJ (1), CGS (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Genzyme Diagnostics P.E.I., Inc.: 2 (https://510kreport.com/company/genzyme-diagnostics-pei)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Diagnostic Chemicals, Ltd. (Usa): 1 (https://510kreport.com/company/diagnostic-chemicals-usa)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Recent decisions
- K202644: Acetaminophen (Feb 18, 2022)
- K182702: SEKURE Creatine Kinase Assay (Apr 17, 2019)
- K180835: SEKURE Acetaminophen L3K Assay (Feb 8, 2019)
- K173206: SEKURE HbA1c Assay (Jul 12, 2018)
- K163078: DC-Uibc-Cal (Dec 8, 2016)
- K111915: Magnesium Assay (Dec 2, 2011)

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