NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides Pteronyssinus

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 Immunoassay Analyzer, Noveos Specific Ige (sige) Assay, Capture Reagent D001, Dermatophagoides Pteronyssinus.

Pre-market Notification Details

Device IDK182479
510k NumberK182479
Device Name:NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides Pteronyssinus
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Hycor Biomedical 7272 Chapman Avenue Garden Grove,  CA  92841
ContactTara Viviani
CorrespondentTara Viviani
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 Received2018-09-10
Decision Date2018-12-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879023503 K182479 000
00816879023008 K182479 000
00816879023015 K182479 000
00816879023022 K182479 000
00816879023039 K182479 000
00816879023046 K182479 000
00816879023053 K182479 000
00816879023077 K182479 000
00816879023091 K182479 000
00816879023107 K182479 000
00816879023114 K182479 000
00816879023169 K182479 000
00816879022995 K182479 000

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