The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Uf1000i.
| Device ID | K070910 |
| 510k Number | K070910 |
| Device Name: | SYSMEX MODEL UF1000I |
| Classification | Counter, Urine Particle |
| Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Contact | Nina M Gamperling |
| Correspondent | Nina M Gamperling SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562408535 | K070910 | 000 |