Cleared Special

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

K160276 · Instrumentation Laboratory CO · Hematology
Mar 2016
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K160276 is an FDA 510(k) clearance for the ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS), 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 March 3, 2016, 30 days after receiving the submission on February 2, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number K160276 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2016
Decision Date March 03, 2016
Days to Decision 30 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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