Cleared Traditional

ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS

K150877 · Instrumentation Laboratory CO · Hematology
Dec 2015
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K150877 is an FDA 510(k) clearance for the ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS, 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 December 13, 2015, 256 days after receiving the submission on April 1, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K150877 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2015
Decision Date December 13, 2015
Days to Decision 256 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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