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 IDBK140139
510k NumberBK140139
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 ProductYes
Date Received2014-03-07
Decision Date2016-10-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07611969952212 BK140139 0
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