510(k) Report

FDA applicant

Chemtrak, Inc.

Sunnyvale, CA7 decisions1991–19971 recall

FDA records 7 decisions for Chemtrak, Inc. (Sunnyvale, CA) from 1991 to 1997: 7 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and LYR (Helicobacter Pylori). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is 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 Chemtrak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chemtrak, Inc. since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Chemtrak, Inc.’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, Cholesterol3decisions
  • LYRHelicobacter Pylori2decisions
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1decision
  • KLSEnzyme Immunoassay, Theophylline1decision

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.

  • K905405Chemtrak Accumeter Cholesterol TestChemtrak, Inc. · 19913cite it

What has FDA decided for it lately?

  • K972495Accumeter Theophylline TestChemtrak, Inc. · 1997
  • K965099Accumeter H. Pylori TestChemtrak, Inc. · 19971 recall
  • K960478Accumeter H. Pylori TestChemtrak, Inc. · 1996
  • K943279Accumeter HDL Cholesterol TestChemtrak, Inc. · 1995
  • K943599Chem Trak AccumeterChemtrak, Inc. · 1995
  • K914432Accumeter (R) Cholesterol Self-TestChemtrak, Inc. · 1993
  • K905405Chemtrak Accumeter Cholesterol TestChemtrak, Inc. · 1991

All 7 as Chemtrak, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K965098M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and…Oct 11, 2013Class II