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ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS - Acl Top Family 50 Series: Acl Top 350 Cts

by Instrumentation Laboratory CO

510(k) K150877

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150877↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK150877 Date13 Dec 2015ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2578-2023 FDA Class II initiated 13 Jul 2023

    Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GKP
Models / Variants
Acl Top Family 50 Series: Acl Top 350 Cts
Device Class
Class II
Regulation
21 CFR Part 864.5400
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ACL TOP Family 50 Series comprises automated coagulation instruments designed for laboratory use. These devices measure clotting times and factors to assess blood coagulation, supporting diagnostic evaluation of bleeding disorders, thrombotic risks, and anticoagulant therapy management. Classified as automated coagulation instruments, they align with the nomenclature for hematology diagnostics, providing quantitative and qualitative coagulation assays.

The ACL TOP series instruments are intended for use in clinical laboratories and are supplied as reusable devices. They are not sterile and require maintenance and calibration per manufacturer instructions. The ACL TOP 350 CTS, ACL TOP 550 CTS, and ACL TOP 750 models include CTS (Coagulation Testing System) capabilities, while the ACL TOP 750 LAS variant incorporates laser-based technology. Authorized under FDA 510(k) clearance and IVDR compliance, these devices operate within Class II regulatory classification and are governed by FDA regulation number 864.5400.

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