K251968

Substantially Equivalent

HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

Applicant: Instrumentation Laboratory (IL) Co.
Product code: KQJ
Advisory panel: Hematology
Date received: 2025-06-26
Decision date: 2025-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

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