Cleared Special

HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL

K251968 · Instrumentation Laboratory (IL) Co. · Hematology
Jul 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251968 is an FDA 510(k) clearance for the HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on July 24, 2025, 28 days after receiving the submission on June 26, 2025. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K251968 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2025
Decision Date July 24, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQJ — System, Fibrinogen Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340