REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826— 510(k) K032139

Name: FDA 510(k) clearance K032139
Creator: U.S. Food and Drug Administration
Published: 2004-04-05

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K032139 for REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826, Substantially Equivalent on 2004-04-05. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2003-07-11
Decision date: 2004-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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