Diagnostic Kit, Cpk

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780311 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• C-Reactive Protein Test Kit

  Class II

  FDA 510(k) K822332 Active Cleared 16 Aug 1982

• Isoenzyme Test Ck-Mb

  Class II

  FDA 510(k) K850212 Active Cleared 7 Feb 1985

• New Enzymatic Single Reagent Free Chol.

  Class I

  FDA 510(k) K822417 Active Cleared 21 Oct 1982

• Acp Kinetic Test (Acid Phosphatase Test)

  Class II

  FDA 510(k) K881204 Active Cleared 28 Apr 1988

• Total Iron Binding Capacity Test

  Class I

  FDA 510(k) K884649 Active Cleared 14 Dec 1988

• Immpulse Coated Tube Phenobarbital Assay Reagents

  Class II

  FDA 510(k) K865000 Active Cleared 6 Feb 1987

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