Cleared Traditional

HEMOSIL FACTOR VIII DEFICIENT PLASMA

K110237 · Instrumentation Laboratory CO · Hematology
Jul 2011
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K110237 is an FDA 510(k) clearance for the HEMOSIL FACTOR VIII 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 July 8, 2011, 163 days after receiving the submission on January 26, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K110237 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2011
Decision Date July 08, 2011
Days to Decision 163 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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