Cleared Traditional

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

K170854 · Instrumentation Laboratory CO · Hematology
Sep 2017
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K170854 is an FDA 510(k) clearance for the HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT 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 September 8, 2017, 170 days after receiving the submission on March 22, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K170854 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2017
Decision Date September 08, 2017
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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