The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Xw-100 Automated Hematology Analyzer, Xw Qc Check.
| Device ID | K143577 |
| 510k Number | K143577 |
| Device Name: | XW-100 Automated Hematology Analyzer, XW QC CHECK |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX AMERICA, INC. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Contact | Peter Shearstone |
| Correspondent | Peter Shearstone SYSMEX AMERICA, INC. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-17 |
| Decision Date | 2015-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987562490216 | K143577 | 000 |