The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Analyzer, Model Cc-720.
Device ID | K790026 |
510k Number | K790026 |
Device Name: | ANALYZER, MODEL CC-720 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | SYSMEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-03 |
Decision Date | 1979-02-08 |