Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Automated Blood Cell Separators.

Pre-market Notification Details

• Device ID: BK950033
• 510k Number: BK950033
• Device Name: Automated Blood Cell Separators
• Classification: Separator, Automated, Blood Cell, Diagnostic
• Applicant: Haemonetics Corporation 400 Wood Road Braintree, MA 02184
• Product Code: GKT
• CFR Regulation Number: 864.9245 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-06
• Decision Date: 1996-04-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30812747019341	BK950033	0
30812747019273	BK950033	0