CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
FDA 510(k) clearance K112586 · decided 2011-10-18
Clearance details
- K-number
- K112586
- Device name
- CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
- Applicant
- Becton, Dickinson and Company (BD)
- Decision
- Substantially Equivalent
- Date received
- 2011-09-06
- Decision date
- 2011-10-18
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- 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
| Record | Firm | Date |
|---|---|---|
| BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility recall (Z-1022-2024) | Becton Dickinson & Co. | 2024-02-08 |