Cleared Traditional

REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826

K032139 · Corgenix, Inc. · Hematology
Apr 2004
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K032139 is an FDA 510(k) clearance for the REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on April 5, 2004, 269 days after receiving the submission on July 11, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K032139 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2003
Decision Date April 05, 2004
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

Similar Devices — GGP Test, Qualitative And Quantitative Factor Deficiency

All 189
CRYOcheck Chromogenic Factor VIII
K251440 · Precision Biologic, Inc. · Aug 2025
HemosIL Chromogenic Factor IX
K230852 · Instrumentation Laboratory Company · Dec 2023
vWF Ag
K220728 · Siemens Healthcare Diagnostics Products GmbH · Jun 2023
CRYOcheck Chromogenic Factor IX
K214002 · Precision Biologic, Inc. · Dec 2022
HemosIL von Willebrand Factor Antigen
K223402 · Instrumentation Laboratory CO · Dec 2022
HemosIL von Willebrand Factor Antigen
K200033 · Instrumentation Laboratory CO · Aug 2020