Cleared Special

ACL TOP

K063679 · Instrumentation Laboratory CO · Hematology
Jan 2007
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K063679 is an FDA 510(k) clearance for the ACL TOP, a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 12, 2007, 32 days after receiving the submission on December 11, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K063679 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2006
Decision Date January 12, 2007
Days to Decision 32 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKP — Instrument, Coagulation, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5400

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