The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Seditainer* Erythrocyte Sedimentation Rate (esr) System.
| Device ID | K953994 |
| 510k Number | K953994 |
| Device Name: | SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene BECTON DICKINSON VACUTAINER SYSTEMS ONE 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 | 1995-08-24 |
| Decision Date | 1995-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903660655 | K953994 | 000 |
| 30382903660651 | K953994 | 000 |