The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Uf-100.
Device ID | K961054 |
510k Number | K961054 |
Device Name: | SYSMEX UF-100 |
Classification | Counter, Urine Particle |
Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Contact | Nina Gamperling |
Correspondent | Nina Gamperling SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Product Code | LKM |
Subsequent Product Code | JIW |
Subsequent Product Code | JJW |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-18 |
Decision Date | 1996-10-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987562408542 | K961054 | 000 |