Etest for Cefuroxime

• • Terminated Z-1226-2017 FDA Class II ·initiated 18 Jan 2017

  Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

510(k) Number

K990722 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• System U3 for Tetracycline

  Class II

  FDA 510(k) K983571 Active Cleared 30 Dec 1998

• ETEST Trovafloxacin

  Class II

  FDA 510(k) K980603 Active Cleared 13 May 1998

• Etest Esbl CT/Ctl Strip; Etest Esbl Tz/Tzl Strip

  Class II

  FDA 510(k) K001547 Active Cleared 7 Aug 2000

• Etest Vancomycin Open recall

  Class II

  FDA 510(k) K980348 Active Cleared 29 May 1998

• Etest Submission for Cefotetan

  Class II

  FDA 510(k) K961517 Active Cleared 5 Jul 1996

• Trimethoprim/Sulphamethoxazole

  Class II

  FDA 510(k) K983027 Active Cleared 2 Oct 1998

See all devices from Ab Biodisk →