510(k) Report

FDA applicant

Biocheck, Inc.

Northridge, CA14 decisions1999–20042 recalls

FDA records 14 decisions for Biocheck, Inc. (Northridge, CA) from 1999 to 2004: 14 510(k) clearances. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Biocheck, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biocheck, Inc. since 2007.

Recalls per year

2in 2021

2021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biocheck, 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?

  • MMIImmunoassay Method, Troponin Subunit2decisions
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone2decisions
  • DCNSystem, Test, C-Reactive Protein1decision
  • KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine1decision
  • JZGSystem, Test, Beta-2-Microglobulin Immunological1decision
  • DGCIge, Antigen, Antiserum, Control1decision

Also: CDP (1), DCK (1), JHI (1), CDZ (1), DBF (1), DRR (1).

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K041619Bio Check Whole Blood/Plasma/Sermon Model #801116Biocheck, Inc. · 2004
  • K040030Biocheck Cardiac-1 CRP Rapid Test, Model BC-804114Biocheck, Inc. · 2004
  • K022660Biocheck Myoglobin Elisa, Model BC-1117Biocheck, Inc. · 2002
  • K013062Biocheck Human Cardiac Troponin-I Immunoassay Test KitBiocheck, Inc. · 2002
  • K003851Biocheck High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit, Model BC-1119Biocheck, Inc. · 2001
  • K002294Biocheck Testosterone Eia, Model BC-1115Biocheck, Inc. · 2000
  • K001022Biocheck, Inc. B-2 Microglobin Enzyme Immunoasay Test Kit, Model BC-1061Biocheck, Inc. · 2000
  • K992517Biocheck Ferritin Elisa Model BC-1025Biocheck, Inc. · 1999

All 14 as Biocheck, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K991432Total Thyroxine (T4) ELISA; REF EIA-1781Oct 18, 2021Class II
  • K991432T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This…Oct 14, 2021Class II