HYCOR BIOMEDICAL

FDA Device Registration & Listing · GARDEN GROVE, CA, US · Registration 2016473

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2016473
FEI Number
1000125787
Entity Name
HYCOR BIOMEDICAL
City/State/Country
GARDEN GROVE, CA, US
Establishment Address
7272 Chapman Ave, GARDEN GROVE, CA 92841, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hycor Biomedical (Owner Number: 2016473)
Owner / Operator Contact Address
7272 Chapman Avenue, Garden Grove, CA 92841, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Noveos Immunoassay Analyzer NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass - G006, Phleum pratense Noveos Immunoassay Analyzer NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus NOVEOS Capture Reagent F013, Peanut (Arachis hypogaea) NOVEOS Capture Reagent F076, Bos d 4 a-lactalbumin, Milk NOVEOS Capture Reagent F232, Gal d 2 Ovalbumin, Egg NOVEOS Capture Reagent F077, Bos d 5 b-lactoglobulin, Milk Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae Noveos Immunoassay Analyzer NOVEOS Specific IgE, Capture Reagent F041, Salmon (Salmo salar) NOVEOS Specific IgE, Capture Reagent F290, Oyster (Ostrea edulis) NOVEOS Specific IgE, Capture Reagent F036, Coconut (Cocos nucifera) NOVEOS Specific IgE, Capture Reagent F075, Egg Yolk (Gallus gallus) NOVEOS Specific IgE, Capture Reagent F040, Tuna (Thunnus sp.) NOVEOS Specific IgE, Capture Reagent F203, Pistachio Nut (Pistacia vera) NOVEOS Specific IgE, Capture Reagent F018, Brazil Nut (Bertholletia excelsa) NOVEOS Specific IgE, Capture Reagent F201, Pecan Nut (Carya illinoensis) NOVEOS Capture Reagent F207, Clam (Mercenaria mercenaria) NOVEOS Capture Reagent F024, Shrimp (Shrimp spp.) NOVEOS Capture Reagent F256, Walnut (Juglans spp.) NOVEOS Capture Reagent I006, German Cockroach (Blatella germanica) Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria NOVEOS Specific IgE, Capture Reagent G008 Meadow Grass, Kentucky Blue NOVEOS Specific IgE, Capture Reagent W010 Goosefoot NOVEOS Specific IgE, Capture Reagent G005 Rye Grass NOVEOS Specific IgE, Capture Reagent W019 Wall Pellitory NOVEOS Specific IgE, Capture Reagent T002 Gray Alder NOVEOS Specific IgE, Capture Reagent M003 Aspergillus fumigatus NOVEOS Specific IgE, Capture Reagent T014 Cottonwood Tree NOVEOS Specific IgE, Capture Reagent T218 Virginia Live Oak – Quercus virginiana NOVEOS Specific IgE, Capture Reagent H001 House Dust - Greer NOVEOS Specific IgE, Capture Reagent W011 Russian Thistle NOVEOS Specific IgE, Capture Reagent T022 Pecan, Hickory NOVEOS Specific IgE, Capture Reagent T010 Walnut NOVEOS Specific IgE, Capture Reagent G009 Redtop, Bentgrass NOVEOS Specific IgE, Capture Reagent G017 Bahia Grass NOVEOS Specific IgE, Capture Reagent T070 Mulberry NOVEOS Specific IgE, Capture Reagent T015 White Ash NOVEOS Specific IgE, Capture Reagent G001 Sweet Vernal Grass NOVEOS Specific IgE, Capture Reagent W009 English Plantain NOVEOS Specific IgE, Capture Reagent F031 Carrot NOVEOS Specific IgE, Capture Reagent G004 Meadow Fescue NOVEOS Specific IgE, Capture Reagent W006 Mugwort NOVEOS Specific IgE, Capture Reagent T001 Maple Box Elder NOVEOS Specific IgE, Capture Reagent M002 Cladosporium herbarum NOVEOS Specific IgE, Capture Reagent T006 Mountain Juniper NOVEOS Specific IgE, Capture Reagent T009 Olive Tree NOVEOS Specific IgE, Capture Reagent T008 Elm NOVEOS Specific IgE, Capture Reagent T011 Maple Leaf Sycamore, London Plane NOVEOS Specific IgE, Capture Reagent W018 Sheep Sorrel NOVEOS Specific IgE, Capture Reagent G003 Cocksfoot NOVEOS Specific IgE, Capture Reagent W014 Common Pigweed

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2018-12-11
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2018-12-11
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2020-07-28
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2020-07-28
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2026-01-20
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2019-08-05
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2019-08-05
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2026-05-20
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2026-01-12
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2023-08-30
DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology Class 2 866.5750 2014-12-11
PUW System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens Immunology Class 2 866.5750 2017-12-26

Official Correspondent

Aashrey Kaul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hycor Biomedical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K872302 Ciba Corning Diagnostics Corp. MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER 1987-09-08
K874883 Incstar Corp. WALNUT ALLERGEN DISC 1988-05-11
K935876 Bio-Rad Laboratories, Inc. ACCESS SPECIFIC IGE ASSAY 1994-03-11
K093987 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 2011-03-28
K132801 Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY 2014-05-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-06 Abbott Laboratories, Inc 1
ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024 Ortho-Clinical Diagnostics, Inc. 1
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06 Beckman Coulter Inc 1
Synchron LX Systems Version 4.5 Operating Software
Z-0010-06 Abbott Laboratories, Inc 1
ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019 Radiometer America Inc 1
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number Establishment Name Location
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1319809 ORTHO-CLINICAL DIAGNOSTICS, INC. ROCHESTER, NY, US
3000308930 Ortho-Clinical Diagnostics European Support Center Illkirch, CEDEX Bas-Rhin, FR
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2016473. Last updated year: 2026. Please use registration number 2016473 when referencing this establishment in official correspondence.
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