Cleared Traditional

GTI-PF4 ELISA

K983379 · Genetic Testing Institute · Hematology
Mar 1999
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K983379 is an FDA 510(k) clearance for the GTI-PF4 ELISA, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Genetic Testing Institute (Brookfield, US). The FDA issued a Cleared decision on March 9, 1999, 165 days after receiving the submission on September 25, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K983379 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1998
Decision Date March 09, 1999
Days to Decision 165 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

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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