Cell-Dyn Calibrator

• • Terminated Z-0246-2007 FDA Unclassified (pre-2012) ·initiated 18 Sep 2006 ·on shared 510(k) K902892

  Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K902892 ↗

FDA Product Code

KRZ

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 864.8165

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

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See all devices from Unipath, Ltd. →