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Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi

by Siemens Healthcare Diagnostics

510(k) K122323

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122323 Date28 Aug 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0134-2021 FDA Class II initiated 25 Aug 2020

    Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well

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  • Withdrawn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
CJO
Device Class
Class II
Regulation
21 CFR Part 862.1050
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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