Cleared Traditional

HEMOSIL FACTOR II DEFICIENT PLASMA

K050661 · Instrumentation Laboratory CO · Hematology
May 2005
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K050661 is an FDA 510(k) clearance for the HEMOSIL FACTOR II 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 May 2, 2005, 48 days after receiving the submission on March 15, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K050661 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2005
Decision Date May 02, 2005
Days to Decision 48 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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