Platelet Antibody Test

Test, Platelet Antibody

Gen-Probe GTI Diagnostics

The following data is part of a premarket notification filed by Gen-probe Gti Diagnostics with the FDA for Platelet Antibody Test.

Pre-market Notification Details

• Device ID: BK050040
• 510k Number: BK050040
• Device Name: Platelet Antibody Test
• Classification: Test, Platelet Antibody
• Applicant: Gen-Probe GTI Diagnostics 20925 Crossroads Circle Waukesha, WI 53186 US
• 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: 2005-07-14
• Decision Date: 2006-01-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234500667	BK050040	0
10888234500285	BK050040	0
10888234500261	BK050040	0