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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record 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 · Hycor Biomedical · decided 2025-04-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
NOVEOS Egg White, Gallus gallusF001HYCOR BIOMEDICAL LLCDHB JJE00816879029901
NOVEOS Bermuda Grass, Cynodon dactylonG002HYCOR BIOMEDICAL LLCDHB JJE00816879023923
NOVEOS Common Silver Birch, Betula verrucosaT003HYCOR BIOMEDICAL LLCDHB JJE00816879023671
NOVEOS Egg White, Gallus gallusF001HYCOR BIOMEDICAL LLCDHB JJE00816879023534
NOVEOS Oak, Quercus albaT007HYCOR BIOMEDICAL LLCDHB JJE00816879023633
NOVEOS Oak, Quercus albaT007HYCOR BIOMEDICAL LLCDHB JJE00816879029857
NOVEOS Common Ragweed, Ambrosia artemisiifoliaW001HYCOR BIOMEDICAL LLCDHB JJE00816879024302
NOVEOS Dog Dander, Canis familiarisE005HYCOR BIOMEDICAL LLCDHB JJE00816879029888
NOVEOS Johnson Grass, Sorghum halepenseG010HYCOR BIOMEDICAL LLCDHB JJE00816879029840
NOVEOS Dog Dander, Canis familiarisE005HYCOR BIOMEDICAL LLCDHB JJE00816879024272
NOVEOS Bermuda Grass, Cynodon dactylonG002HYCOR BIOMEDICAL LLCDHB JJE00816879029864
NOVEOS Common Silver Birch, Betula verrucosaT003HYCOR BIOMEDICAL LLCDHB JJE00816879029895
NOVEOS Johnson Grass, Sorghum halepenseG010HYCOR BIOMEDICAL LLCDHB JJE00816879024227
NOVEOS Cow's Milk, Bos taurusF002HYCOR BIOMEDICAL LLCDHB JJE00816879023541
NOVEOS Cow's Milk, Bos taurusF002HYCOR BIOMEDICAL LLCDHB JJE00816879029918
NOVEOS Common Ragweed, Ambrosia artemisiifoliaW001HYCOR BIOMEDICAL LLCDHB JJE00816879029871