Accucolor High Calibrator (A3089)

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K973274 ↗

FDA Product Code

GIZ

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K872451 Active Cleared 21 Aug 1987

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  FDA 510(k) K954839 Active Cleared 5 Jan 1996

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  Class I

  FDA 510(k) K932067 Active Cleared 16 Jun 1993

See all devices from Sigma Diagnostics, Inc. →