Kit, Quality Control For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

ALBA Bioscience Limited (doing Business As Quotient)

The following data is part of a premarket notification filed by Alba Bioscience Limited (doing Business As Quotient) with the FDA for Kit, Quality Control For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK080027
510k NumberBK080027
Device Name:Kit, Quality Control For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant ALBA Bioscience Limited (doing Business As Quotient) 21 Ellen's Glen Road liberton, Edinburgh Scotland, United Kingdom,  EH17 7QT,  UK
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-09
Decision Date2008-07-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060242471513 BK080027 0

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