The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Uf-100i Automated Urine Cell Analyzer.
Device ID | K053135 |
510k Number | K053135 |
Device Name: | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER |
Classification | Counter, Urine Particle |
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 | LKM |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-11-08 |
Decision Date | 2006-01-04 |
Summary: | summary |