HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL— 510(k) K251968

Name: FDA 510(k) clearance K251968
Creator: U.S. Food and Drug Administration
Published: 2025-07-24

Substantially Equivalent

Instrumentation Laboratory (IL) Co.

FDA 510(k) clearance K251968 for HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL, Substantially Equivalent on 2025-07-24. Applicant: Instrumentation Laboratory (IL) Co.. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory (IL) Co.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 2025-06-26
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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