Ames Tda Primidone Test

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K802654 ↗

FDA Product Code

DJD

Device Class

Class II

Regulation

21 CFR Part 862.3680

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Ames TDA TM Primidone Test

  Class II

  FDA 510(k) K811007 Active Cleared 29 Apr 1981

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  FDA 510(k) K853021 Active Cleared 7 Aug 1985

• Lab-Tek Fta-Abs Kit

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  FDA 510(k) K801928 Active Cleared 20 Aug 1980

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  Class I

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  Class I

  FDA 510(k) K875079 Active Cleared 5 Apr 1988

• Reagent Strips for Urinalysis

  Class I

  FDA 510(k) K811342 Active Cleared 1 Sep 1981

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