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Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30

by Genzyme Diagnostics P.E.I., Inc.

510(k) K081938

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081938 Date1 May 2009ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-3118-2017 FDA Class II initiated 20 Jul 2017

    Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.

    • Terminated Z-1171-2016 FDA Class II initiated 22 Jan 2016

    Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

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  • Withdrawn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
LDP
Device Class
Class II
Regulation
21 CFR Part 862.3030
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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