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Acon Urinalysis Reagent Strips

by Acon Laboratories Co.

510(k) K061559

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK061559 Date11 Aug 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2786-2018 FDA Class III initiated 22 Jun 2018

    Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.

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  • Withdrawn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
CDM
Device Class
Class I
Regulation
21 CFR Part 862.1785
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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