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Dimension Tshl Flex Reagent Cartridge and Tsh Sample Diluent with Models Rf 612 and KD691

by Siemens Healthcare Diagnostics, Inc.

510(k) K081074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Special NumberK081074 Date23 May 2008ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1882-2013 FDA Class II initiated 10 May 2013
    • Terminated Z-1883-2013 FDA Class II initiated 10 May 2013

    A rare variant of TSH, identified in a small cluster of patients, is not detected.

    • Terminated Z-0459-2011 FDA Unclassified (pre-2012) initiated 12 Apr 2010

    Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.

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  • Withdrawn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
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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