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 |