Coulter Counter Model S-Plus Stkr

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871837 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K897161 Active Cleared 1 Mar 1990

• Coulter Direct Billrubin Reagent

  Class II

  FDA 510(k) K905622 Active Cleared 26 Dec 1990

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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

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