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510(k) K062025

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 by Corgenix, Inc. — Product Code OBW

K062025 is an FDA 510(k) premarket notification submitted by Corgenix, Inc. for the device "ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136". The FDA issued a decision of Substantially Equivalent on May 29, 2007. The device falls under product code OBW (11-Dehydro Thromboxane B2 Kit, Urinary), a Class II device regulated under 21 CFR 864.5700. Corgenix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
July 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
11-Dehydro Thromboxane B2 Kit, Urinary
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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.

Other clearances by Corgenix, Inc.

  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)
  • K032139 — REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 (April 5, 2004)
  • K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (January 8, 2004)
  • K032868 — REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (October 14, 2003)
  • K031208 — REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 (July 7, 2003)
  • K024195 — MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT (January 3, 2003)
  • K024196 — REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT (January 3, 2003)
  • K022990 — REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (September 25, 2002)
  • K022992 — REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 (September 25, 2002)

FDA data resources