The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Anti-leu-12 B Cell Reagent.
| Device ID | K851639 |
| 510k Number | K851639 |
| Device Name: | ANTI-LEU-12 B CELL REAGENT |
| Classification | Assay, B Lymphocyte Marker |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Contact | Russell J Arnsberge |
| Correspondent | Russell J Arnsberge BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | LJD |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-19 |
| Decision Date | 1986-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903492091 | K851639 | 000 |