Data / Medical devices / United States / Hycor Biomedical

Hycor Biomedical: FDA-registered device maker in Garden Grove, CA, United States, 11 510(k) clearances

Name: Hycor Biomedical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hycor Biomedical is registered with the FDA (registration 2016473) in Garden Grove, CA, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 24, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2016473
FEI number: 1000125787
Address: 7272 Chapman Ave, Garden Grove, CA, United States, 92841
Owner or operator: Hycor Biomedical (2016473)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: July 17, 2013
Registered through: 2026
Brand names listed: NOVEOS Capture Reagent F010, Sesame Seed (Sesamum indicum), NOVEOS Capture Reagent F013, Peanut (Arachis hypogaea), NOVEOS Capture Reagent F014, Soybean (Glycine max), NOVEOS Capture Reagent F017, Hazelnut (Corylus avellana), NOVEOS Capture Reagent F020, Almond (Amygdalus communis), NOVEOS Capture Reagent F024, Shrimp (Shrimp spp.), NOVEOS Capture Reagent F076, Bos d 4 a-lactalbumin, Milk, NOVEOS Capture Reagent F077, Bos d 5 b-lactoglobulin, Milk and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Test, Radioallergosorbent (Rast) Immunological	DHB	2	Complaint file establishment, Manufacturer, Manufacturer for export	accessdata.fda.gov
System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens	PUW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 24, 2026	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	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
July 21, 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	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
June 18, 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	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
May 15, 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)	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
January 16, 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	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
December 23, 2025	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)	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
April 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	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
February 18, 2022	K220162	Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
June 26, 2020	K200825	NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
July 31, 2019	K191510	Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov
December 4, 2018	K182479	NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus	DHB	Substantially Equivalent	Hycor Biomedical	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 25, 2018	83853	Class II	Ongoing	HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; an	Some of the Stop Solution bottles, a caustic solution, have been reported to leak.	accessdata.fda.gov
March 19, 2018	83268	Class II	Ongoing	HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Pa	Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG. The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.	accessdata.fda.gov
February 21, 2018	82952	Class II	Completed	AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immuno	Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.	accessdata.fda.gov

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Updated July 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.