# Hycor Biomedical, Inc.

- Location (FDA's records): Garden Grove, CA
- FDA decisions: 66 (1989–2026): 66 510(k) clearances
- Names in FDA's records: Hycor Biomedical, Inc. (51); Hycor Biomedical (11); Hycor Biomedical , Ltd. (4)
- Product codes: DHB (24), LLL (10), MSV (3), DKB (3), LRM (2), LYR (2), LKJ (2), DHR (2), MVM (2), JNL (2), LDJ (1), DBM (1)
- 510(k) review time since 2016: median 132 days, against 138 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 13 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pharmacia Diagnostics, Inc.: 11 (https://510kreport.com/company/pharmacia-diagnostics)

## Firms that cite its devices most
- Inova Diagnostics, Inc.: 1 (https://510kreport.com/company/inova-diagnostics)
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Its most-cited devices
- K941278: HY-Tec Automated Eia System (1995), cited by 2
- K962719: Hycor HY.Tec/Manual SS-a Auto-Antibody (1997), cited by 1
- K920856: Ventrex Coated Tube High Sensit. TSH Radioimmunoas (1992), cited by 1

## Recent decisions
- K261027: NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut (Jul 24, 2026)
- K260591: NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut (Jul 21, 2026)
- K260280: NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg (Jun 18, 2026)
- K260059: NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) (May 15, 2026)
- K252775: NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk;  Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (Jan 16, 2026)
- K252493: NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (Dec 23, 2025)
- K242531: NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (Apr 23, 2025)
- K220162: Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria (Feb 18, 2022)

Source page: https://510kreport.com/company/hycor-biomedical