The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Anti-human Leu-2a (cd8) Pe.
| Device ID | K904390 |
| 510k Number | K904390 |
| Device Name: | ANTI-HUMAN LEU-2A (CD8) PE |
| Classification | Counter, Differential Cell |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1990-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903400461 | K904390 | 000 |