Platelet Antibody Test

Test, Platelet Antibody

Cooper Biomedical

The following data is part of a premarket notification filed by Cooper Biomedical with the FDA for Platelet Antibody Test.

Pre-market Notification Details

• Device ID: BK850008
• 510k Number: BK850008
• Device Name: Platelet Antibody Test
• Classification: Test, Platelet Antibody
• Applicant: Cooper Biomedical 1 Technology Court Malvern, PA 29355
• Product Code: MYP
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-04-19
• Decision Date: 1986-01-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234001027	BK850008	0