Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

• • Terminated Z-1199-2007 FDA Unclassified (pre-2012) ·initiated 11 May 2007

  The product failed electrostatic discharge testing, which could result in product failure.

510(k) Number

K913305 ↗

FDA Product Code

GKZ

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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