510(k) Report

FDA applicant

General Biometrics, Inc.

San Diego, CA23 decisions1989–19921 recall

FDA records 23 decisions for General Biometrics, Inc. (San Diego, CA) from 1989 to 1992: 23 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and LLL (Extractable Antinuclear Antibody, Antigen And…). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for General Biometrics, 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 — General Biometrics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like General Biometrics, 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?

  • LSRReagent, Borrelia Serological Reagent4decisions
  • LLLExtractable Antinuclear Antibody, Antigen And Control3decisions
  • LFXEnzyme Linked Immunoabsorbent Assay, Rubella3decisions
  • MIDSystem, Test, Anticardiolipin Immunological2decisions
  • LKOAnti-Rnp Antibody, Antigen And Control2decisions
  • LKPAnti-Sm Antibody, Antigen And Control2decisions

Also: JNL (2), LJM (2), DHC (1), JZO (1), KTN (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K905486Immunowell Tpo (Microsome) TestGeneral Biometrics, Inc. · 19911cites it
  • K905485Immunowell Thyroglobulin TestGeneral Biometrics, Inc. · 19911cites it

What has FDA decided for it lately?

  • K924843Immunodot (R) Ena/Dna Autoimmunity Screening PanelGeneral Biometrics, Inc. · 1992
  • K920401Immunowell Cardiolipin Antibody (Igm) TestGeneral Biometrics, Inc. · 1992
  • K920400Immunowell Cardiolipin Antibody (Igg) TestGeneral Biometrics, Inc. · 1992
  • K911627Immunodot Borrelia (Lyme) TestGeneral Biometrics, Inc. · 1992
  • K911599Immunowell Lyme (P39 Recombinant) TestGeneral Biometrics, Inc. · 1991
  • K911590Immunowell Borrelia (Lyme)TestGeneral Biometrics, Inc. · 19911 recall
  • K914801Immunowell Dsdna Antibody TestGeneral Biometrics, Inc. · 1991
  • K911849Immunowell Sjogrens Syndrome a (RO)Antibody TestGeneral Biometrics, Inc. · 1991

All 23 as General Biometrics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K911590ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package…Feb 11, 2013Class II