ENTEROCOCCUS SCREENING MEDIUM
FDA 510(k) clearance K951539 · decided 1995-06-13
Clearance details
- K-number
- K951539
- Device name
- ENTEROCOCCUS SCREENING MEDIUM
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1995-04-03
- Decision date
- 1995-06-13
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cockeysville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vancomycin Screen Agar recall (Z-0473-2016) | Becton Dickinson & Co. | 2015-12-23 |
| Enterococcus Screen Agar QUAD Plate recall (Z-0474-2016) | Becton Dickinson & Co. | 2015-12-23 |
| BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test recall (Z-2628-2014) | Becton Dickinson & Co. | 2014-09-12 |
| BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***B recall (Z-1798-2013) | Becton Dickinson & Co. | 2013-07-24 |