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Susceptibility Test Plate for Ertapenem 0.002-16UG/Ml for Gram Negative. Susceptibility Test Plate for Ertapenem 0.015-

by Tds Holdings, Inc.

510(k) K060621

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060621 Date21 Apr 2006ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0329-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0332-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0331-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0333-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0327-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0328-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0334-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0335-2023 FDA Class I initiated 20 Oct 2022
    • Terminated Z-0330-2023 FDA Class I initiated 20 Oct 2022

    An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

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  • Withdrawn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
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent