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Blood Establishment Computer Software And Accessories

CSL Plasma

The following data is part of a premarket notification filed by Csl Plasma 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: BK190430
• 510k Number: BK190430
• 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: CSL Plasma 900 Broken Sound Parkway suite 400 Boca Raton, FL 33487
• 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: 2019-12-13
• Decision Date: 2020-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860007397615	BK190430	0