The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Kx-21, Automated Hematology Analyzer.
Device ID | K981761 |
510k Number | K981761 |
Device Name: | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | SYSMEX CORP. ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
Contact | Nina Gamperling |
Correspondent | Nina Gamperling SYSMEX CORP. ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-19 |
Decision Date | 1998-08-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04987562429219 | K981761 | 000 |