Cleared Special

HEMOSIL FIBRINOGEN-C

K073367 · Instrumentation Laboratory CO · Hematology
Dec 2007
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K073367 is an FDA 510(k) clearance for the HEMOSIL FIBRINOGEN-C, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 27, 2007, 27 days after receiving the submission on November 30, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K073367 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2007
Decision Date December 27, 2007
Days to Decision 27 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

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