Atlas FDA

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML

FDA 510(k) clearance K070809 · decided 2007-09-24

Clearance details

K-number
K070809
Device name
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
Applicant
Becton, Dickinson & CO
Decision
Substantially Equivalent
Date received
2007-03-26
Decision date
2007-09-24
Days to decision
182 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 PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and recall (Z-0232-2023)Becton Dickinson & Co.2022-11-14
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson an recall (Z-0570-2013)Becton Dickinson & Co.2012-12-19