Bd Phoenix Automated Microbiology System - Cephalothin (Gp) 0.5-64 Ug/Ml

• • Terminated Z-0181-2008 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007 ·on shared 510(k) K050400

  Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.

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

510(k) Number

K050400 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

  Class II

  FDA 510(k) K030677 Active Cleared 1 Apr 2003

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  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

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• Bd Pen Needle

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• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

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