BLOOD CELL PROCESSOR MODEL 2 IBM 2991

Separator, Automated, Blood Cell, Diagnostic

INTL. BUSINESS MACHINES

The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Blood Cell Processor Model 2 Ibm 2991.

Pre-market Notification Details

• Device ID: K760856
• 510k Number: K760856
• Device Name: BLOOD CELL PROCESSOR MODEL 2 IBM 2991
• Classification: Separator, Automated, Blood Cell, Diagnostic
• Applicant: INTL. BUSINESS MACHINES 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GKT
• CFR Regulation Number: 864.9245 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-10-15
• Decision Date: 1977-01-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
35020583908193	K760856	000
05020583908192	K760856	000