RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA— 510(k) K920981

Name: FDA 510(k) clearance K920981
Creator: U.S. Food and Drug Administration
Published: 1992-04-17

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K920981 for RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA, Substantially Equivalent on 1992-04-17. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Product code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-03-02
Decision date: 1992-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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