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

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..

Clearance details

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

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