The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Counter, Differential Cell.
|Device Name:||Counter, Differential Cell|
|Classification||Counter, Differential Cell|
|Applicant||Sysmex America, Inc. 577 Aptakisic Rd Lincolnshire, IL 60069|
|CFR Regulation Number||864.5220 [🔎]|
|Decision||Substantially Equivalent (SE)|
|3rd Party Reviewed||No|