Atlas FDA

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML

FDA 510(k) clearance K060218 · decided 2006-03-17

Clearance details

K-number
K060218
Device name
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2006-01-27
Decision date
2006-03-17
Days to decision
49 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

No recalls on record reference this clearance.