Enzymatic Reagent for Cholesterol Meas

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781013 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Coulter Total Protein Reagent

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• Chemistry, Coulter

  Class I

  FDA 510(k) K770679 Active Cleared 3 May 1977

See all devices from Coulter Electronics, Inc. →