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Dimension Ammonia Flex Reagent Cartridge

by Siemens Healthcare Diagnostics 510(k)

Active United States

510(k) K123320

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123320 Date15 Feb 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

3 recalls · FDA

    • Terminated Z-1649-2018 FDA Class II initiated 29 Jun 2017

    Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.

    • Terminated Z-1140-2017 FDA Class II initiated 16 Dec 2016

    Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.

    • Terminated Z-1141-2017 FDA Class II initiated 16 Dec 2016

    Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.

Specification

510(k)

510(k) Number
FDA Product Code
JIF
Device Class
Class I
Regulation
21 CFR Part 862.1065
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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