Cleared Special

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

K242127 · Instrumentation Laboratory (IL) Co. · Hematology

Aug 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K242127 is an FDA 510(k) clearance for the ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS), a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP), submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on August 16, 2024, 28 days after receiving the submission on July 19, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number	K242127 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2024
Decision Date	August 16, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF