Atlas FDA

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

FDA 510(k) clearance K040099 · decided 2004-03-19

Clearance details

K-number
K040099
Device name
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2004-01-20
Decision date
2004-03-19
Days to decision
59 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sparks, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiol recall (Z-0239-2026)Becton Dickinson & Co.2025-10-23
BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 4436 recall (Z-0592-2025)Becton Dickinson & Co.2024-12-03
BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial su recall (Z-3246-2024)Becton Dickinson & Co.2024-09-24
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility recall (Z-3247-2024)Becton Dickinson & Co.2024-09-24