Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Medion Grifols Diagnostics AG

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

Pre-market Notification Details

Device IDBK140092
510k NumberBK140092
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Medion Grifols Diagnostics AG bonnstrasse 9 Duedingen,  Switzerland,  3186, 
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-07
Decision Date2014-04-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.