ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136

11-dehydro Thromboxane B2 Kit, Urinary

CORGENIX, INC.

The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Aspirinworks Test Kit (11-dehydro Thromboxane B2), Model 12136.

Pre-market Notification Details

• Device ID: K062025
• 510k Number: K062025
• Device Name: ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
• Classification: 11-dehydro Thromboxane B2 Kit, Urinary
• Applicant: CORGENIX, INC. 11575 MAIN ST. SUITE 400 Broomfield, CO 80020
• Contact: Kimberly N Hassler
• Correspondent: Kimberly N Hassler; CORGENIX, INC. 11575 MAIN ST. SUITE 400 Broomfield, CO 80020
• Product Code: OBW
• CFR Regulation Number: 864.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-18
• Decision Date: 2007-05-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855360006274	K062025	000