BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML
FDA 510(k) clearance K060214 · decided 2006-03-09
Clearance details
- K-number
- K060214
- Device name
- BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2006-01-27
- Decision date
- 2006-03-09
- Days to decision
- 41 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.