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 ID: BK140092
• 510k Number: BK140092
• Device Name: Quality Control Kits For Blood Banking Reagents
• Classification: Kit, Quality Control For Blood Banking Reagents
• Applicant: Medion Grifols Diagnostics AG bonnstrasse 9 Duedingen, Switzerland, 3186,
• Product Code: KSF
• CFR Regulation Number: 864.9650 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-07
• Decision Date: 2014-04-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640137340605	BK140092	0