Platelet Antibody Test

Test, Platelet Antibody

Genetic Testing Institute

The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Platelet Antibody Test.

Pre-market Notification Details

• Device ID: BK950004
• 510k Number: BK950004
• Device Name: Platelet Antibody Test
• Classification: Test, Platelet Antibody
• Applicant: Genetic Testing Institute 1701 W. Wisconsin Avenue, Suite 429 Milwaukee, WI 53233
• 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: 1994-10-26
• Decision Date: 1995-05-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234500629	BK950004	0
10888234500520	BK950004	0
10888234500230	BK950004	0