Modified Seralyzer Alt/Sgpt Reag. Strips & Module

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K875079 ↗

FDA Product Code

CKA

Device Class

Class I

Regulation

21 CFR Part 862.1030

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ames TDA TM Primidone Test

  Class II

  FDA 510(k) K811007 Active Cleared 29 Apr 1981

• Optimate Digoxin Test

  Class II

  FDA 510(k) K853021 Active Cleared 7 Aug 1985

• Lab-Tek Fta-Abs Kit

  Class II

  FDA 510(k) K801928 Active Cleared 20 Aug 1980

• Hema-Tek Ii Slide Stainer

  Class I

  FDA 510(k) K771559 Active Cleared 25 Aug 1977

• Ames Tda Primidone Test

  Class II

  FDA 510(k) K802654 Active Cleared 12 Nov 1980

• Reagent Strips for Urinalysis

  Class I

  FDA 510(k) K811342 Active Cleared 1 Sep 1981

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