FDA applicant

Alere San Diego, Inc.

San Diego, CA2 decisions2015–20230 recalls

FDA records 2 decisions for Alere San Diego, Inc. (San Diego, CA) from 2015 to 2023: 2 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and LYR (Helicobacter Pylori). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Alere San Diego, Incorporated”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Alere San Diego, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Alere San Diego, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alere San Diego, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Alere”

FDA records each applicant name separately; these may or may not be the same firm.

Alere Scarborough, Inc. 17 Alere Scarborough, Inc D/B/A Binax, Inc. 4 Alere Technologies AS 3 Alere, San Diego, Dba Biosite INcorporated, Dba IN 1 Alere, Inc. 1 Alere San Diego, Inc (Formally Biosite Incorporate 1 Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen 1

Alere San Diego, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Alere”