The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Xt-series Ig Parameter,sysmex Xt-series Ret-he Parameter.
| Device ID | K081890 |
| 510k Number | K081890 |
| Device Name: | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Contact | Carrie Pineda |
| Correspondent | Carrie Pineda SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-10-10 |
| Summary: | summary |