The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Xw-100 Automated Hematology Analyzer For Clia Waived Use.
| Device ID | K172604 |
| 510k Number | K172604 |
| Device Name: | XW-100 Automated Hematology Analyzer For CLIA Waived Use |
| Classification | Counter, Differential Cell |
| Applicant | Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Contact | Michelle Abraham |
| Correspondent | Michelle Abraham Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-30 |
| Decision Date | 2017-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562490110 | K172604 | 000 |