ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136— 510(k) K062025

Name: FDA 510(k) clearance K062025
Creator: U.S. Food and Drug Administration
Published: 2007-05-29

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K062025 for ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136, Substantially Equivalent on 2007-05-29. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code OBW
Device class: Class 2
Regulation: 21 CFR 864.5700
Advisory panel: Hematology
Date received: 2006-07-18
Decision date: 2007-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

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