The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Erma Pc-604 Blood Cell Counter.
| Device ID | K854677 |
| 510k Number | K854677 |
| Device Name: | ERMA PC-604 BLOOD CELL COUNTER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Contact | Morad Daoudzadeh |
| Correspondent | Morad Daoudzadeh FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deerpark, NY 11729 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-20 |
| Decision Date | 1986-02-24 |