510(k) K120615 ยท CGA Glucose Oxidase, Glucose
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
| Applicant | Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen, San Diego CA, US |
| Decision | Substantially Equivalent, May 15, 2013 |
| Received | Feb 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2024 | Alere San Diego, Inc. Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 Open, Classified |
CGA | None listed |
| Jun 24, 2022 | Alere San Diego, Inc. The Cholestech LDX System combines enzymatic methodology and solidphase
technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples
used for testing can be whole blood Open, Classified |
CGA | None listed |
| Feb 15, 2019 | Alere San Diego, Inc. Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and Terminated |
JJE | None listed |
| Aug 2, 2016 | Alere San Diego, Inc. LDX Optical Check Cassettes (OCC)
Model Number: 10-228 and 14-535
Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer.
Product Usage:
The Optics Che Terminated |
LBS | None listed |
| Nov 22, 2013 | Alere San Diego, Inc. Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991.
Product Generic Name: Alere Cholestech LDX Lipid Profile"GLU Test Cassette.
Description of the product: Lipid Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.