Hematology Reference Control

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771753 ↗

FDA Product Code

JPK

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Retic-C Cell Control

  Class II

  FDA 510(k) K930119 Active Cleared 5 Apr 1993

• Coulter Uric Acid Reagent

  Class I

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• Coulter Direct Billrubin Reagent

  Class II

  FDA 510(k) K905622 Active Cleared 26 Dec 1990

• Coulter Counter-Blood Cell Counter

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  FDA 510(k) K792668 Active Cleared 29 Jan 1980

• 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. →