MEROPENEM, 10 MCG, SENSI-DISC
FDA 510(k) clearance K963845 · decided 1996-10-25
Clearance details
- K-number
- K963845
- Device name
- MEROPENEM, 10 MCG, SENSI-DISC
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-09-25
- Decision date
- 1996-10-25
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cockeysville, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Becton Dickinson Microbiology Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility tes recall (Z-1033-2024) | Becton Dickinson & Co. | 2024-02-08 |