Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Alba Bioscience Limited

The following data is part of a premarket notification filed by Alba Bioscience Limited with the FDA for Quality Control Kits For Blood Banking Reagents.

Pre-market Notification Details

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• Device ID: BK180286
• 510k Number: BK180286
• Device Name: Quality Control Kits For Blood Banking Reagents
• Classification: Kit, Quality Control For Blood Banking Reagents
• Applicant: Alba Bioscience Limited james Hamilton Way Penicuik, Midlothian, EH26 0BF, UK
• 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: 2018-11-19
• Decision Date: 2019-02-05