510(k) K981013 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE
| Applicant | Becton Dickinson Vacutainer Systems, Franklin Lake NJ, US |
| Decision | Substantially Equivalent for Some Indications, Jun 17, 1998 |
| Received | Mar 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981013
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2018 | Becton Dickinson & Company BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (U Terminated |
JKA | None listed |
| Mar 22, 2018 | Becton Dickinson & Company BD Vacutainer EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 50382903680493); 4. 368589 (UDI: 50382903685894) Terminated |
JKA | None listed |
| Dec 31, 2015 | Becton Dickinson & Company BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x
2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA
The Vacutainer Brand PLUS (Plastic) Tube with EDTA Terminated |
JKA | None listed |
| Dec 31, 2015 | Becton Dickinson & Company BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x
2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA
BD Vacutainer tubes are used to collect, transpor Terminated |
JKA | None listed |
| Dec 31, 2015 | Becton Dickinson & Company BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x
3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA
BD Vacutainer tubes are used to collect, tran Terminated |
JKA | None listed |
| Dec 31, 2015 | Becton Dickinson & Company BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x
3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA
BD Vacutainer tubes are used to collect, transport Terminated |
JKA | None listed |
| Dec 31, 2015 | Becton Dickinson & Company BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x
4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA
BD Vacutainer tubes are used to collect, tran Terminated |
JKA | None listed |
| Dec 21, 2015 | Becton Dickinson & Company BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes.
Product Usage:
BD Vacutainer tubes are used to collect, transport and process blood in a closed system. These tubes are used for testin Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.