Cleared Traditional

IL TEST PT FIBRINOGEN HS

K923921 · Instrumentation Laboratory CO · Hematology
Oct 1992
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K923921 is an FDA 510(k) clearance for the IL TEST PT FIBRINOGEN HS, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 26, 1992, 82 days after receiving the submission on August 5, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K923921 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1992
Decision Date October 26, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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