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Blood Establishment Computer Software And Accessories

Grifols Diagnostic Solutions Inc.

The following data is part of a premarket notification filed by Grifols Diagnostic Solutions Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK140150
• 510k Number: BK140150
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Blood Establishment Computer Software And Accessories
• Applicant: Grifols Diagnostic Solutions Inc. 4560 Horton Street, M/s N-200 Emeryville, CA 94608 US
• Product Code: MMH
• CFR Regulation Number: 864.9165 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-11
• Decision Date: 2014-08-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00866489000012	BK140150	0
00866489000005	BK140150	0