Norfloxacin Antimicrobial Susceptibility Test Disc

• • Terminated Z-0793-2014 FDA Class II ·initiated 9 Apr 2013

  Cartridges may contain individual discs which were not impregnated with antibiotic.

510(k) Number

K964491 ↗

FDA Product Code

JTN

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

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. →