510(k) Report

FDA applicant

Hycor Biomedical, Inc.

Garden Grove, CA66 decisions1989–20261 recall

FDA records 66 decisions for Hycor Biomedical, Inc. (Garden Grove, CA) from 1989 to 2026: 66 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and LLL (Extractable Antinuclear Antibody, Antigen And…). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Hycor Biomedical”, “Hycor Biomedical , Ltd.”.

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 Hycor Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 22018: 12019: 12020: 12022: 12025: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hycor Biomedical, 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?

  • DHBSystem, Test, Radioallergosorbent (Rast) Immunological24decisions
  • LLLExtractable Antinuclear Antibody, Antigen And Control10decisions
  • MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)3decisions
  • DKBCalibrators, Drug Mixture3decisions
  • LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control2decisions
  • LYRHelicobacter Pylori2decisions

Also: LKJ (2), DHR (2), MVM (2), JNL (2), LDJ (1), DBM (1).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 138 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K941278HY-Tec Automated Eia SystemHycor Biomedical, Inc. · 19952cite it
  • K962719Hycor HY.Tec/Manual SS-a Auto-AntibodyHycor Biomedical, Inc. · 19971cites it
  • K920856Ventrex Coated Tube High Sensit. TSH RadioimmunoasHycor Biomedical, Inc. · 19921cites it

What has FDA decided for it lately?

  • K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut…Hycor Biomedical · 2026
  • K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond…Hycor Biomedical · 2026
  • K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab…Hycor Biomedical · 2026
  • K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036…Hycor Biomedical · 2026
  • K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4…Hycor Biomedical · 2026
  • K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam…Hycor Biomedical · 2025
  • K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent…Hycor Biomedical · 2025
  • K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaHycor Biomedical · 2022

All 51 as Hycor Biomedical, Inc. →All 11 as Hycor Biomedical →All 4 as Hycor Biomedical, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081217HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution…Jul 25, 2018Class II