HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY— 510(k) K930235

Name: FDA 510(k) clearance K930235
Creator: U.S. Food and Drug Administration
Published: 1993-09-02

Substantially Equivalent

Technidyne Corp.

FDA 510(k) clearance K930235 for HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY, Substantially Equivalent on 1993-09-02. Applicant: Technidyne Corp.. Device class: 2.

Clearance details

Applicant: Technidyne Corp.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1993-01-05
Decision date: 1993-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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