The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Reticcount Software.
| Device ID | K880636 |
| 510k Number | K880636 |
| Device Name: | RETICCOUNT SOFTWARE |
| 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 | 1988-02-16 |
| Decision Date | 1988-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903431731 | K880636 | 000 |
| 00382903431304 | K880636 | 000 |