VACUTAINER BRAND PLUS SERUM & SST TUBES
FDA 510(k) clearance K960250 · decided 1996-03-29
Clearance details
- K-number
- K960250
- Device name
- VACUTAINER BRAND PLUS SERUM & SST TUBES
- Applicant
- Becton Dickinson Vacutainer Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-01-16
- Decision date
- 1996-03-29
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Numbe recall (Z-2629-2014) | Fresenius Medical Care Holdings, Inc. | 2014-09-12 |
| BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: recall (Z-2631-2014) | Fresenius Medical Care Holdings, Inc. | 2014-09-12 |
| BD Vactuainer SST glass and plastic tubes. recall (Z-0052-05) | Becton Dickinson & Company | 2004-10-28 |