Cleared Traditional

PF4 IGG

K071781 · Genetic Testing Institute · Hematology
Dec 2007
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K071781 is an FDA 510(k) clearance for the PF4 IGG, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Genetic Testing Institute (Waukesha, US). The FDA issued a Cleared decision on December 19, 2007, 170 days after receiving the submission on July 2, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K071781 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2007
Decision Date December 19, 2007
Days to Decision 170 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LCO — Platelet Factor 4 Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7695

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