Counter Model S Plus Blood Cell Counter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K771512 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Chemistry, Coulter

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  FDA 510(k) K770679 Active Cleared 3 May 1977

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