BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BECTON, DICKINSON & CO.

The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Phoenix Automated Microbiology System, Vancomycin (strep) 0.0625 -32 Ug/ml.

Pre-market Notification Details

• Device ID: K050745
• 510k Number: K050745
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
• Classification: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
• Applicant: BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999
• Contact: Monica E Giguere
• Correspondent: Monica E Giguere; BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999
• Product Code: LON
• CFR Regulation Number: 866.1645 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-22
• Decision Date: 2005-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382904488032	K050745	000
30382904488025	K050745	000
30382902460092	K050745	000
30382902460078	K050745	000