Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Blackhawk BioSystems,Inc.

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

Pre-market Notification Details

Device IDBK930034
510k NumberBK930034
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Blackhawk BioSystems,Inc. 12945 Alcosta Blvd. San Ramon,  CA  94583
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-06
Decision Date1994-07-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847661004684 BK930034 000
00847661004585 BK930034 000

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