Cleared Traditional

ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)

K073377 · Instrumentation Laboratory CO · Hematology
May 2008
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K073377 is an FDA 510(k) clearance for the ACL TOP (WITH SYSTEM SOFTWARE V3.0.0), 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 May 4, 2008, 153 days after receiving the submission on December 3, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K073377 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2007
Decision Date May 04, 2008
Days to Decision 153 days
Submission Type Traditional
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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