Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

DIAGAST

The following data is part of a premarket notification filed by Diagast with the FDA for Quality Control Kits For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK160084
510k NumberBK160084
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant DIAGAST parc Eurasanté 251, Avenue Eugéne Avinée Loos Cedex,  59374,  FR
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-19
Decision Date2018-02-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
23661562105438 BK160084 0

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