The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Xs-1000ic Automated Hematology Analyzer.
| Device ID | K081610 |
| 510k Number | K081610 |
| Device Name: | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling 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 | 2008-06-09 |
| Decision Date | 2008-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562412860 | K081610 | 000 |