Cardiozyme Plus Ck-Total #65046

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K803169 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultra Zyme Plus Ck-1 #64978, 65027 & 28

  Class II

  FDA 510(k) K812593 Active Cleared 2 Oct 1981

• Ultrachem Phosphorus, 64973

  Class I

  FDA 510(k) K772156 Active Cleared 6 Dec 1977

• Ultrachem Total Protein, #64974

  Class II

  FDA 510(k) K772155 Active Cleared 6 Dec 1977

• Ultrazyme Plus Alp

  Class II

  FDA 510(k) K770870 Active Cleared 14 Jul 1977

• Ultra Zyme Plus Gpt, #64956, 65035 & 36

  Class I

  FDA 510(k) K812591 Active Cleared 24 Sep 1981

• Ultrazyme Alkaline Phosphatase

  Class II

  FDA 510(k) K760024 Active Cleared 26 Aug 1976

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