Cleared Traditional

HemosIL CL HIT-IgG(PF4-H)

K243374 · Instrumentation Laboratory (IL) Co. · Hematology
Jan 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243374 is an FDA 510(k) clearance for the HemosIL CL HIT-IgG(PF4-H), a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on January 28, 2025, 90 days after receiving the submission on October 30, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K243374 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2024
Decision Date January 28, 2025
Days to Decision 90 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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