The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Uf-1000i, Automated Urine Particle Analyzer With Urinalysis Wam Software.
Device ID | K080887 |
510k Number | K080887 |
Device Name: | SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-31 |
Decision Date | 2008-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00664369000639 | K080887 | 000 |