510(k) Report

FDA applicant

Biotrack, Inc.

Mountain View, CA16 decisions1986–19931 recall

FDA records 16 decisions for Biotrack, Inc. (Mountain View, CA) from 1986 to 1993: 16 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and DIP (Enzyme Immunoassay, Diphenylhydantoin). 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 toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Biotrack, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use3decisions
  • DIPEnzyme Immunoassay, Diphenylhydantoin1decision
  • GJSTest, Time, Prothrombin1decision
  • KLTEnzyme Immunoassay, Carbamazepine1decision
  • LAWTheophylline Control Materials1decision
  • KHGWhole Blood Hemoglobin Determination1decision

Also: GFO (1), CJJ (1), GIT (1), DIF (1), KLS (1), DIS (1).

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.

  • K890052Biotrack Aptt Reagent CartridgeBiotrack, Inc. · 19891cites it
  • K890051Biotrack Aptt ControlsBiotrack, Inc. · 19891cites it
  • K860720Biotrack Monitor (Biotrack Reagent Cartridges)Biotrack, Inc. · 19861cites it

What has FDA decided for it lately?

  • K934062Biotrack Therapeutic Drug-Monitoring Qual ControlsBiotrack, Inc. · 1993
  • K934061Biotrack Valproic Acid Test CartridgeBiotrack, Inc. · 1993
  • K920525Biotrack Therapeutic Drug Monitoring Qual. ControlBiotrack, Inc. · 1992
  • K915755Biotrack Phenytoin Test CartridgeBiotrack, Inc. · 1992
  • K915756Biotrack Carbamazepine Test CartridgeBiotrack, Inc. · 1992
  • K903924Biotrack Theophylline Quality ControlsBiotrack, Inc. · 1990
  • K900373Biotrack Theophylline Test CartridgeBiotrack, Inc. · 1990
  • K900372Biotrack Immunochemistry MonitorBiotrack, Inc. · 1990

All 16 as Biotrack, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K860719CoaguChek Plus meter; catalog # 475729 and 12816001.Mar 12, 2003