The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Facscan Flow Cytometer - Reticcount Reti. Enu. Kit.
| Device ID | K872166 |
| 510k Number | K872166 |
| Device Name: | FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | J Arnsberger |
| Correspondent | J Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-05 |
| Decision Date | 1987-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903431731 | K872166 | 000 |
| 00382903431304 | K872166 | 000 |