Quantitative Control Urine II (Human)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792376 ↗

FDA Product Code

JJW

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Carcinoembryonic Antigen (Cea) Control

  Class II

  FDA 510(k) K792377 Active Cleared 26 Sep 1980

• Lypoprotein Cholesterol Test Kit

  Class I

  FDA 510(k) K780173 Active Cleared 3 May 1978

• Tdm Anti-Convulsant Control Levels I-II

  Class I

  FDA 510(k) K811811 Active Cleared 10 Jul 1981

• Glucose Kit

  Class II

  FDA 510(k) K761320 Active Cleared 25 Jan 1977

• Gamma-Glutamyl Transpeptidase (Ggt)

  Class I

  FDA 510(k) K803089 Active Cleared 2 Jan 1981

• Anti-Arrhythmic Control Levels I & II

  Class I

  FDA 510(k) K811809 Active Cleared 10 Jul 1981

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