# Alere San Diego, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2015–2023): 2 510(k) clearances
- Names in FDA's records: Alere San Diego, Inc. (1); Alere San Diego, Incorporated (1)
- Product codes: CGA (1), LYR (1)
- Predicates its devices cite: 2 (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
- Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen: 1 (https://510kreport.com/company/alere-san-diego-dba-biosite-innovacon-hemosen)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Recent decisions
- K223179: Cholestech LDX ™ System (Sep 20, 2023)
- K151935: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only (Aug 12, 2015)

Source page: https://510kreport.com/company/alere-san-diego