Slavo Cholesterol Stand. Diagnostic Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800770 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K850212 Active Cleared 7 Feb 1985

• New Enzymatic Single Reagent Free Chol.

  Class I

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• Acp Kinetic Test (Acid Phosphatase Test)

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• Total Iron Binding Capacity Test

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