Atlas FDA

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST

FDA 510(k) clearance K033458 · decided 2004-05-28

Clearance details

K-number
K033458
Device name
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2003-10-30
Decision date
2004-05-28
Days to decision
211 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" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in recall (Z-1847-2011)Becton Dickinson & Co.2011-03-30