Cleared Traditional

HEMOSIL FACTOR XII DEFICIENT PLASMA

K043459 · Instrumentation Laboratory CO · Hematology
Feb 2005
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K043459 is an FDA 510(k) clearance for the HEMOSIL FACTOR XII DEFICIENT PLASMA, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 9, 2005, 56 days after receiving the submission on December 15, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K043459 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2004
Decision Date February 09, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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