The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Uf-100.
| Device ID | K961054 |
| 510k Number | K961054 |
| Device Name: | SYSMEX UF-100 |
| Classification | Counter, Urine Particle |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | LKM |
| Subsequent Product Code | JIW |
| Subsequent Product Code | JJW |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562408542 | K961054 | 000 |