Beckman Epsilon(Tm) Prolactin Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864439 ↗

FDA Product Code

CFT

Device Class

Class I

Regulation

21 CFR Part 862.1625

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

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• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

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• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

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