510(k) Report

FDA applicant

Bio-Chem Laboratory Systems, Inc.

Lakewood, NJ5 decisions1992–19951 recall

FDA records 5 decisions for Bio-Chem Laboratory Systems, Inc. (Lakewood, NJ) from 1992 to 1995: 5 510(k) clearances. Most are in product codes JJE (Analyzer, Chemistry (Photometric, Discrete)…) and KHO (Fluorometer, For Clinical Use). 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 Bio-Chem Laboratory Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Chem Laboratory Systems, Inc. since 2007.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bio-Chem Laboratory Systems, 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?

  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use2decisions
  • KHOFluorometer, For Clinical Use1decision
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone1decision
  • CDXRadioimmunoassay, Total Thyroxine1decision

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.

  • K945271Atac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc. · 19951cites it

What has FDA decided for it lately?

  • K945271Atac 8000 Random Access Chemistry SystemBio-Chem Laboratory Systems, Inc. · 19951 recall
  • K930689Autobead Thyroid UptakeBio-Chem Laboratory Systems, Inc. · 1993
  • K930006Autobead TSH Enzyme Immunoassay Reagent KitBio-Chem Laboratory Systems, Inc. · 1993
  • K926563Autobead (TM) T4 Enzyme Immunoassay Test KitBio-Chem Laboratory Systems, Inc. · 1993
  • K924084Atac 6000 Chemistry AnalyzerBio-Chem Laboratory Systems, Inc. · 1992

All 5 as Bio-Chem Laboratory Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K945271ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level…Apr 18, 2017Class II