Rapid Direct Strep a Latex Agglutination Test

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K852841 ↗

FDA Product Code

GTZ

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Esklab Reagent Tablets

  Class II

  FDA 510(k) K790918 Active Cleared 22 Jun 1979

• Spinchem Acid Phosphatase Reagent

  Class II

  FDA 510(k) K821674 Active Cleared 22 Jun 1982

• Target Isocheck Control Serum

  Class I

  FDA 510(k) K821183 Active Cleared 14 May 1982

• S.K. Diag. Ultrasound Body Scanner

  Class II

  FDA 510(k) K800532 Active Cleared 10 Apr 1980

• Spin-Chem Triglycerides Reagent

  Class I

  FDA 510(k) K812471 Active Cleared 14 Sep 1981

• Spin Chem Reagents & Standards

  Class I

  FDA 510(k) K821184 Active Cleared 24 May 1982

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