Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Bio-Rad Medical Diagnostics GmbH

The following data is part of a premarket notification filed by Bio-rad Medical Diagnostics Gmbh with the FDA for Quality Control Kits For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK170064
510k NumberBK170064
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Bio-Rad Medical Diagnostics GmbH industriestrasse 1 Dreieich,  63303,  GM
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-19
Decision Date2017-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07611969952342 BK170064 0
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