Medical Device Manufacturer · US , Garden Grove , CA

Hycor Biomedical

7 submissions · 7 cleared · Since 2018
7
Total
7
Cleared
0
Denied

Hycor Biomedical — FDA 510(k) Submissions

Hycor Biomedical has submitted 7 FDA 510(k) premarket notifications since 2018, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
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 ?-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
K252775 · DHB System, Test,... · Immunology
Jan 2026 136d
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)
K252493 · DHB System, Test,... · Immunology
Dec 2025 137d
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
K242531 · DHB System, Test,... · Immunology
Apr 2025 240d
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
K220162 · DHB System, Test,... · Immunology
Feb 2022 29d
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
K200825 · DHB System, Test,... · Immunology
Jun 2020 88d
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
K191510 · DHB System, Test,... · Immunology
Jul 2019 55d
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
K182479 · DHB System, Test,... · Immunology
Dec 2018 85d
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