Latex Agglutination Test

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K851132 ↗

FDA Product Code

GTZ

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Neisseria Gonorrhoeae Test

  Class II

  FDA 510(k) K820007 Active Cleared 29 Jan 1982

• Rapid Bacteriuria Screen (Rbs)

  Class I

  FDA 510(k) K862195 Active Cleared 30 Jun 1986

• Syphilis Serological Reagents

  Class II

  FDA 510(k) K871226 Active Cleared 28 May 1987

• Pyloriscreen

  Class I

  FDA 510(k) K925190 Active Cleared 23 Mar 1993

• Cholerascreen

  Class II

  FDA 510(k) K922432 Active Cleared 7 Dec 1992

• Rapid Colorimetric Direct Strep a Test

  Class I

  FDA 510(k) K874761 Active Cleared 19 Feb 1988

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