The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer(r) Brand Plus Pst(tm) Plasma Separation Tube.
| Device ID | K945952 |
| 510k Number | K945952 |
| Device Name: | VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Eileen T Schweighardt |
| Correspondent | Eileen T Schweighardt BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-06 |
| Decision Date | 1995-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903697415 | K945952 | 000 |
| 50382903678728 | K945952 | 000 |
| 50382903678711 | K945952 | 000 |
| 50382903677295 | K945952 | 000 |
| 50382903676717 | K945952 | 000 |
| 50382903675871 | K945952 | 000 |
| 50382903666640 | K945952 | 000 |
| 30382903680352 | K945952 | 000 |
| 30382903679622 | K945952 | 000 |
| 30382903679615 | K945952 | 000 |
| 30382903679608 | K945952 | 000 |
| 30382903680369 | K945952 | 000 |
| 30382903679646 | K945952 | 000 |
| 30382903679639 | K945952 | 000 |
| 50382903678780 | K945952 | 000 |
| 50382903678841 | K945952 | 000 |
| 50382903678865 | K945952 | 000 |
| 50382903697149 | K945952 | 000 |
| 50382903688246 | K945952 | 000 |
| 50382903680561 | K945952 | 000 |
| 50382903680332 | K945952 | 000 |
| 50382903680264 | K945952 | 000 |
| 50382903679640 | K945952 | 000 |
| 50382903679633 | K945952 | 000 |
| 50382903679626 | K945952 | 000 |
| 50382903679619 | K945952 | 000 |
| 50382903679602 | K945952 | 000 |
| 50382903679251 | K945952 | 000 |
| 50382903679220 | K945952 | 000 |
| 50382903679213 | K945952 | 000 |
| 30382903680567 | K945952 | 000 |