BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
FDA 510(k) clearance K024240 · decided 2003-03-26
Clearance details
- K-number
- K024240
- Device name
- BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
- Applicant
- Bd
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-03-26
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- JSM
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Urine Cup Kit with C&S Preservative Tube for Midstream specimens; 50; Becton recall (Z-1023-2010) | Becton Dickinson & Company | 2010-03-08 |
| BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream spec recall (Z-1024-2010) | Becton Dickinson & Company | 2010-03-08 |
| BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for M recall (Z-1025-2010) | Becton Dickinson & Company | 2010-03-08 |