BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

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.

Pre-market Notification Details

• Device ID: K020321
• 510k Number: K020321
• Device Name: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
• Classification: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
• Applicant: BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999
• Contact: Bradford M Spring
• Correspondent: Bradford M Spring; 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: 2002-01-15
• Decision Date: 2002-05-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902460115	K020321	000
30382902460061	K020321	000
30382902460047	K020321	000
30382902460030	K020321	000
00382902460169	K020321	000
00382902460152	K020321	000