510(k) Report

FDA applicant

Cholestech Corp.

Hayward, CA20 decisions1990–20045 recalls

FDA records 20 decisions for Cholestech Corp. (Hayward, CA) from 1990 to 2004: 20 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and CGA (Glucose Oxidase, Glucose). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Cholestech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cholestech Corp. since 2007.

Recalls per year

2in 2013

2010: 12011: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cholestech Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • CHHEnzymatic Esterase--Oxidase, Cholesterol10decisions
  • CGAGlucose Oxidase, Glucose2decisions
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl2decisions
  • CKDHydrazone Colorimetry, Alt/Sgpt1decision
  • JGYColorimetric Method, Triglycerides1decision
  • JJYMulti-Analyte Controls, All Kinds (Assayed)1decision

Also: CIS (1), DCK (1), CDN (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K904082Cholestech Lipid Monitoring System, Glucose TestCholestech Corp. · 19901cites it
  • K946067Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCholestech Corp. · 19951cites it
  • K954778Cholestech LDX SystemCholestech Corp. · 19951cites it

What has FDA decided for it lately?

  • K040579Choletech LDX High-Sensitivity C-Reactive Protein (HS-CRP)Cholestech Corp. · 20042 recalls
  • K032027Cholestech LDX Aspartate Aminotransferase (Ast)Cholestech Corp. · 20031 recall
  • K991834Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772Cholestech Corp. · 19991 recall
  • K972012Cholestech Bun/Creatinine Test SystemCholestech Corp. · 1997
  • K954778Cholestech LDX SystemCholestech Corp. · 1995
  • K946064Total Cholesterol CassetteCholestech Corp. · 1995
  • K946063Total Cholesterol and HDL Cholesterol PanelCholestech Corp. · 1995
  • K946065Total Cholesterolm HDL Cholesterol and Triglycerides PanelCholestech Corp. · 1995

All 20 as Cholestech Corp. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K040579The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette…Mar 6, 2013Class II
  • K032027Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative…Mar 6, 2013Class II
  • K904082Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104…Feb 18, 2011
  • K901900Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.Nov 16, 2010
  • K040579Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The…Aug 9, 2006