The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Plus Tube With Edta Anticoagulant Andd Vacutainer Plus Serum Tube.
| Device ID | K981013 |
| 510k Number | K981013 |
| Device Name: | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Eileen Schweighardt |
| Correspondent | Eileen Schweighardt BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-18 |
| Decision Date | 1998-06-17 |
| Summary: | summary |