Anti-Arrhythmic Control Levels I & II

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K811809 ↗

FDA Product Code

DIF

Device Class

Class I

Regulation

21 CFR Part 862.3280

Advisory Committee

Clinical Toxicology

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

• Quantitative Control Urine II (Human)

  Class I

  FDA 510(k) K792376 Active Cleared 6 Dec 1979

• Gamma-Glutamyl Transpeptidase (Ggt)

  Class I

  FDA 510(k) K803089 Active Cleared 2 Jan 1981

See all devices from Environmental Chemical Specialties →