The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Se/ram-1.
| Device ID | K964375 |
| 510k Number | K964375 |
| Device Name: | SYSMEX SE/RAM-1 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Catherine M Trester, Mt(ascp) |
| Correspondent | Catherine M Trester, Mt(ascp) SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-03-13 |
| Summary: | summary |