Ck-Mb(Immunological)

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K802521 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Autotransfusion Apparatus

  Class II

  FDA 510(k) K873807 Active Cleared 9 Mar 1988

• Adr-22 Automatic Dialyzer Reprocessor

  Class II

  FDA 510(k) K874034 Active Cleared 23 Oct 1987

• Bca 1000

  Class I

  FDA 510(k) K810105 Active Cleared 2 Feb 1981

• Infumix Mixing Container

  Class II

  FDA 510(k) K870052 Active Cleared 27 Feb 1987

• Biodynamics Model Bi-400 Body Composition Analyzer

  Class II

  FDA 510(k) K881968 Active Cleared 28 Jul 1988

• Biodynamics Model Bi-300 Body Composition Analyzer

  Class II

  FDA 510(k) K874361 Active Cleared 16 Mar 1988

See all devices from Biodynamics Corp. →