Bd Phoenix Automated Microbiology System-Clindamycin 0.125-8.0mcg/Ml

• • Terminated Z-0366-2011 FDA Unclassified (pre-2012) ·initiated 14 May 2010

  The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.

510(k) Number

K021954 ↗

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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