The following data is part of a premarket notification filed by Bd Vacutainer Systems Preanalyical Solutions with the FDA for Bd Vacutainer Plus Sst Serum Separator Tube.
| Device ID | K023075 |
| 510k Number | K023075 |
| Device Name: | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS 1 BECTON DRIVE, MCC 300 Franklin Lakes, NJ 07417 -1885 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS 1 BECTON DRIVE, MCC 300 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 | 2002-09-16 |
| Decision Date | 2002-11-25 |
| Summary: | summary |