Cleared Special

ACL TOP 970 CL

K233790 · Instrumentation Laboratory · Hematology
Dec 2023
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K233790 is an FDA 510(k) clearance for the ACL TOP 970 CL, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Instrumentation Laboratory (Bedford, US). The FDA issued a Cleared decision on December 29, 2023, 31 days after receiving the submission on November 28, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K233790 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2023
Decision Date December 29, 2023
Days to Decision 31 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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