510(k) Report

FDA applicant

Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen

San Diego, CA1 decision2013–20135 recalls

FDA records 1 decision for Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen (San Diego, CA) in 2013: 1 510(k) clearance. All are in product code CGA (Glucose Oxidase, Glucose). 5 recalls are linked to its devices.

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. Dba Biosite,Innovacon,Hemosen’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2024

2013: 12016: 12019: 12022: 12024: 1
2013high 1 (2013) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120615Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu CassetteAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen · 20131cites it

What has FDA decided for it lately?

  • K120615Alere Cholestech LDX Analyzer, Alere Cholestech LDX Lipid Profile - Glu CassetteAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen · 20135 recalls

The one decision as Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K120615Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170Mar 1, 2024Class II
  • K120615The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to…Jun 24, 2022Class II
  • K120615Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the…Feb 15, 2019Class II
  • K120615LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with…Aug 2, 2016Class III
  • K120615Product Brand Name (s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model…Oct 23, 2013Class III

Other applicant names beginning “Alere”

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

Alere Scarborough, Inc. 17Alere Scarborough, Inc D/B/A Binax, Inc. 4Alere Technologies AS 3Alere San Diego, Inc. 2Alere, San Diego, Dba Biosite INcorporated, Dba IN 1Alere, Inc. 1Alere San Diego, Inc (Formally Biosite Incorporate 1