Cleared Traditional

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

K153137 · Instrumentation Laboratory CO · Hematology
Jul 2016
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K153137 is an FDA 510(k) clearance for the HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on July 8, 2016, 252 days after receiving the submission on October 30, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K153137 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2015
Decision Date July 08, 2016
Days to Decision 252 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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