Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides Farinae

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 Immunoanalyzer System, Noveos Specific Ige (slge), Capture Reagent D002, Dermatophagoides Farinae.

Pre-market Notification Details

Device IDK191510
510k NumberK191510
Device Name:Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides Farinae
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant Hycor Biomedical 7272 Chapman Avenue Garden Grove,  CA  92841
ContactKaitlyn Weinkauf
CorrespondentKaitlyn Weinkauf
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 Received2019-06-06
Decision Date2019-07-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879023510 K191510 000

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