HemosIL CL HIT-IgG(PF4-H)— 510(k) K243374

Name: FDA 510(k) clearance K243374
Creator: U.S. Food and Drug Administration
Published: 2025-01-28

Substantially Equivalent

Instrumentation Laboratory (IL) Co.

FDA 510(k) clearance K243374 for HemosIL CL HIT-IgG(PF4-H), Substantially Equivalent on 2025-01-28. Applicant: Instrumentation Laboratory (IL) Co.. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory (IL) Co.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 2024-10-30
Decision date: 2025-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCO

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K201570 — PF4 Enhanced assay2020-09-11
K201311 — PF4 IgG assay2020-06-18
K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls2017-09-08
K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls2016-07-08
K071781 — PF4 IGG2007-12-19

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