The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Ppt Plasma Preparation Tube.
| Device ID | K972075 |
| 510k Number | K972075 |
| Device Name: | VACUTAINER BRAND PPT PLASMA PREPARATION TUBE |
| Classification | Blood/plasma Collection Device For Dna Testing |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | John Schalago |
| Correspondent | John Schalago BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | PJE |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-03 |
| Decision Date | 1998-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903628013 | K972075 | 000 |
| 50382903628006 | K972075 | 000 |
| 50382903627993 | K972075 | 000 |
| 50382903627917 | K972075 | 000 |
| 50382903627887 | K972075 | 000 |
| 30382903627999 | K972075 | 000 |
| 30382903627883 | K972075 | 000 |