Cleared Traditional

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

K062025 · Corgenix, Inc. · Hematology
May 2007
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K062025 is an FDA 510(k) clearance for the ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136, a 11-dehydro Thromboxane B2 Kit, Urinary (Class II — Special Controls, product code OBW), submitted by Corgenix, Inc. (Broomfield, US). The FDA issued a Cleared decision on May 29, 2007, 315 days after receiving the submission on July 18, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K062025 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2006
Decision Date May 29, 2007
Days to Decision 315 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code OBW — 11-dehydro Thromboxane B2 Kit, Urinary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700
Definition The Test Kit Is An Enzyme-linked Immunoassay (elisa) To Determine Levels Of 11-dehydro Thromboxane B2 (11dhtxb2) In Human Urine, Which Aids In The Qualitative Detection Of Aspirin Effect In Apparently Healthy Individuals Post Ingestion. For Professional Use Only.