Bd Phoenix Automated Microbiology System - Confirmatory Esbl Test

• • Terminated Z-1847-2011 FDA Unclassified (pre-2012) ·initiated 28 Feb 2011

  In vitro diagnostic test kit is defective and may cause false positive or false negative results.

510(k) Number

K033458 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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