Cleared Special

PF4 ENHANCED SOLID PHASE ELISA

K053559 · Genetic Testing Institute · Hematology
Jan 2006
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K053559 is an FDA 510(k) clearance for the PF4 ENHANCED SOLID PHASE ELISA, 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 January 20, 2006, 30 days after receiving the submission on December 21, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K053559 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2005
Decision Date January 20, 2006
Days to Decision 30 days
Submission Type Special
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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