ERTAPENEM 10UG BBL SENSI-DISC
FDA 510(k) clearance K020842 · decided 2002-05-15
Clearance details
- K-number
- K020842
- Device name
- ERTAPENEM 10UG BBL SENSI-DISC
- Applicant
- Becton, Dickinson & CO
- Decision
- Substantially Equivalent
- Date received
- 2002-03-15
- Decision date
- 2002-05-15
- Days to decision
- 61 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 Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1030-2024) | Becton Dickinson & Co. | 2024-02-08 |