CD8 Cytospheres Kit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K923951 ↗

FDA Product Code

MAM

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class I

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  Class II

  FDA 510(k) K905622 Active Cleared 26 Dec 1990

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• Chemistry, Coulter

  Class I

  FDA 510(k) K770679 Active Cleared 3 May 1977

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