Streptex ZL01

• 2 recalls, same reason

  • Terminated Z-0538-2014 FDA Class II ·initiated 2 May 2013
  • Terminated Z-0537-2014 FDA Class II ·initiated 2 May 2013

  The product may give weak or false negative test results.

510(k) Number

K842828 ↗

FDA Product Code

JTO

Device Class

Class I

Regulation

21 CFR Part 866.2660

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Streptex Acid Extraction Kit

  Class I

  FDA 510(k) K910797 Active Cleared 29 Mar 1991

• Wellcogen H. Influenzal ZL21

  Class I

  FDA 510(k) K833077 Active Cleared 10 Jan 1984

• Wellcogen Bacterial Antigen Kit

  Class II

  FDA 510(k) K854852 Active Cleared 4 Feb 1986

• Fibri-Prest Automate HA34 Open recall

  Class II

  FDA 510(k) K840211 Active Cleared 2 Mar 1984

• Streptex Direct a ZL14

  Class I

  FDA 510(k) K842827 Active Cleared 16 Aug 1984

• Diacrom * Atiii

  Class II

  FDA 510(k) K832592 Active Cleared 29 Sep 1983

See all devices from Wellcome Diagnostics →