The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Vacutainer Safety Coagulation Tube.
| Device ID | K013971 |
| 510k Number | K013971 |
| Device Name: | BD VACUTAINER SAFETY COAGULATION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Keith Smith |
| Correspondent | Keith Smith BECTON DICKINSON & CO. 1 BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903665605 | K013971 | 000 |
| 30382903630807 | K013971 | 000 |
| 30382903630838 | K013971 | 000 |
| 50382903630474 | K013971 | 000 |
| 50382903630481 | K013971 | 000 |
| 50382903630801 | K013971 | 000 |
| 50382903630832 | K013971 | 000 |
| 50382903630955 | K013971 | 000 |
| 50382903643054 | K013971 | 000 |
| 30382903665601 | K013971 | 000 |