FACTOR VIII ANTIBODY SCREEN— 510(k) K082205

Name: FDA 510(k) clearance K082205
Creator: U.S. Food and Drug Administration
Published: 2008-11-20

Substantially Equivalent

Genetic Testing Institute

FDA 510(k) clearance K082205 for FACTOR VIII ANTIBODY SCREEN, Substantially Equivalent on 2008-11-20. Applicant: Genetic Testing Institute. Device class: 2.

Clearance details

Applicant: Genetic Testing Institute
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2008-08-05
Decision date: 2008-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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