NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum Pratense

System, Test, Radioallergosorbent (rast) Immunological

Hycor Biomedical

The following data is part of a premarket notification filed by Hycor Biomedical with the FDA for Noveos Specific Ige (sige), Capture Reagent Cat Dander - E001, Felis Domesticus; Noveos Specific Ige (sige), Capture Reagent Timothy Grass- G006, Phleum Pratense.

Pre-market Notification Details

Device IDK200825
510k NumberK200825
Device Name:NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum Pratense
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Hycor Biomedical 7272 Chapman Avenue Garden Grove,  CA  92841
ContactIrene M. Guzman
CorrespondentIrene M. Guzman
Hycor Biomedical 7272 Chapman Avenue Garden Grove,  CA  92841
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-06-26

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