Atlas FDA

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML

FDA 510(k) clearance K051266 · decided 2005-07-05

Clearance details

K-number
K051266
Device name
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2005-05-16
Decision date
2005-07-05
Days to decision
50 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.