Ultrazyme Plus Ck-I

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K821883 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultrachem T-Bili

  Class II

  FDA 510(k) K821873 Active Cleared 14 Jul 1982

• Ultrachem T.P.

  Class II

  FDA 510(k) K821879 Active Cleared 14 Jul 1982

• Ultrachem Tri-Es

  Class I

  FDA 510(k) K821875 Active Cleared 13 Jul 1982

• Ultrachem Bun-UV, 65080 & 65081

  Class II

  FDA 510(k) K822323 Active Cleared 2 Sep 1982

• Cpk Ultrazyme Plus

  Class II

  FDA 510(k) K770694 Active Cleared 1 Jul 1977

• Ultrazyme Plus 2GT

  Class I

  FDA 510(k) K821871 Active Cleared 14 Jul 1982

See all devices from Harleco Diagnostics →