BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
FDA 510(k) clearance K023075 · decided 2002-11-25
Clearance details
- K-number
- K023075
- Device name
- BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE
- Applicant
- Bd Vacutainer Systems Preanalyical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2002-09-16
- Decision date
- 2002-11-25
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367 recall (Z-2055-2018) | Becton Dickinson & Company | 2018-06-01 |
| BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 36 recall (Z-2056-2018) | Becton Dickinson & Company | 2018-06-01 |
| BD Vactuainer SST glass and plastic tubes. recall (Z-0052-05) | Becton Dickinson & Company | 2004-10-28 |