The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Uf1000i.
Device ID | K070910 |
510k Number | K070910 |
Device Name: | SYSMEX MODEL UF1000I |
Classification | Counter, Urine Particle |
Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
Contact | Nina M Gamperling |
Correspondent | Nina M 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 | 2007-04-02 |
Decision Date | 2007-05-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987562408535 | K070910 | 000 |