Cleared Special

ACL AcuStar

K170314 · Instrumentation Laboratory CO · Hematology
Mar 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K170314 is an FDA 510(k) clearance for the ACL AcuStar, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 3, 2017, 30 days after receiving the submission on February 1, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K170314 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2017
Decision Date March 03, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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