Systemate Total Bilirubin Catalog No. 65407

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895118 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Alanine Aminotransferase Test

  Class I

  FDA 510(k) K903198 Active Cleared 12 Sep 1990

• Emds Tm Phenobarbital(Phno) Testpack, #67677/95

  Class II

  FDA 510(k) K864926 Active Cleared 7 Jan 1987

• Olympus(Tm) Total Bilirubin

  Class II

  FDA 510(k) K897174 Active Cleared 10 May 1990

• Systamate Aspartate Aminotransferase Test Technico

  Class II

  FDA 510(k) K922857 Active Cleared 9 Sep 1992

• Systemate (Tm) Alanine Transferase (Alt)

  Class II

  FDA 510(k) K863094 Active Cleared 29 Aug 1986

• Systemate Ldh, 67210

  Class II

  FDA 510(k) K843269 Active Cleared 13 Sep 1984

See all devices from Em Diagnostic Systems, Inc. →