Cleared Traditional

FACTOR VIII ANTIBODY SCREEN

K082205 · Genetic Testing Institute · Hematology
Nov 2008
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K082205 is an FDA 510(k) clearance for the FACTOR VIII ANTIBODY SCREEN, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Genetic Testing Institute (Waukesha, US). The FDA issued a Cleared decision on November 20, 2008, 107 days after receiving the submission on August 5, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K082205 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2008
Decision Date November 20, 2008
Days to Decision 107 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

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