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ACL AcuStar

by Instrumentation Laboratory CO

510(k) K170314

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Special NumberK170314 Date3 Mar 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JPA
Device class
Class II
Regulation
21 CFR Part 864.5425
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 AcuStar is an automated in‑vitro coagulation analysis system classified as a Class II device. It is designed for multipurpose coagulation studies in the hemostasis laboratory, providing chemiluminescent detection for a range of assays.

The system was cleared by the FDA through a 510(k) submission (K170314) with a special clearance type and is listed under product code JPA. It is manufactured by Instrumentation Laboratory CO in Bedford, MA, United States, and is supplied as a complete system for laboratory use.

Other devices from Instrumentation Laboratory Company

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the ACL AcuStar used for?

    The ACL AcuStar is designed for multipurpose coagulation studies in the hemostasis laboratory, providing chemiluminescent detection for a range of assays to support automated in-vitro coagulation analysis.

  • How is the ACL AcuStar supplied and for what setting is it intended?

    The ACL AcuStar is supplied as a complete system for laboratory use, intended for automated coagulation testing in clinical hemostasis laboratories.

  • What regulatory pathway was used for the ACL AcuStar and what is its classification?

    The ACL AcuStar was cleared by the FDA through a 510(k) submission (K170314) and is classified as a Class II device under product code JPA.