Cleared Traditional

HEMOSIL LA POSITIVE CONTROL

K102552 · Instrumentation Laboratory CO · Hematology
Apr 2011
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K102552 is an FDA 510(k) clearance for the HEMOSIL LA POSITIVE CONTROL, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on April 5, 2011, 210 days after receiving the submission on September 7, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K102552 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2010
Decision Date April 05, 2011
Days to Decision 210 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425