510(k) Report

FDA applicant

Hemagen Diagnostics, Inc.

Waltham, MA52 decisions1986–20041 recall

FDA records 52 decisions for Hemagen Diagnostics, Inc. (Waltham, MA) from 1986 to 2004: 52 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2…). Its devices cite 14 predicates, 8 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Hemagen Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hemagen Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLLExtractable Antinuclear Antibody, Antigen And Control16decisions
  • MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)3decisions
  • DCKC-Reactive Protein, Antigen, Antiserum, And Control3decisions
  • MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)3decisions
  • MIDSystem, Test, Anticardiolipin Immunological3decisions
  • DHRSystem, Test, Rheumatoid Factor2decisions

Also: JIX (2), DHN (2), CDQ (2), CFR (2), KHS (1), CJY (1).

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 8 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.

  • K932373Hemagen Cardiolipin Antibody Kit (Eia METHOD0Hemagen Diagnostics, Inc. · 19934cite it
  • K944288Hemagen C-Reactive Protein Kit (Eia Method)Hemagen Diagnostics, Inc. · 19942cite it
  • K855221Seratest RF (Hemagglutination) KitHemagen Diagnostics, Inc. · 19862cite it
  • K941840Hemagen Acl Iga CalibratorHemagen Diagnostics, Inc. · 19942cite it
  • K930272Hemagen Chagas' Kit (Eia Method)Hemagen Diagnostics, Inc. · 19951cites it

What has FDA decided for it lately?

  • K041051Raichem Bun Rate Reagent (Liquid)Hemagen Diagnostics, Inc. · 2004
  • K041052Raichem Glucose UV (Liquid)Hemagen Diagnostics, Inc. · 2004
  • K041009Raichem Calcium (Ocpc) Liquid ReagentHemagen Diagnostics, Inc. · 20041 recall
  • K031101Raichem Assayed Control Serum Level 1 & 2Hemagen Diagnostics, Inc. · 2003
  • K023784Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerHemagen Diagnostics, Inc. · 2002
  • K022772Raichem LDL-Cholesterol Direct ReagentHemagen Diagnostics, Inc. · 2002
  • K022767Raichem Lipid CalibratorHemagen Diagnostics, Inc. · 2002
  • K021194Raichem CRP High Sensitivity Test SystemHemagen Diagnostics, Inc. · 2002

All 52 as Hemagen Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041009Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro…Jun 7, 2006