VON WILLEBRAND FACTOR ASSAY— 510(k) K823453

Name: FDA 510(k) clearance K823453
Creator: U.S. Food and Drug Administration
Published: 1983-01-21

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K823453 for VON WILLEBRAND FACTOR ASSAY, Substantially Equivalent on 1983-01-21. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Product code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1982-11-17
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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