The following data is part of a premarket notification filed by Nanoentek, Inc. with the FDA for Test, Residual, Wbc In Leukoreduced Blood.
|Device Name:||Test, Residual, WBC In Leukoreduced Blood|
|Classification||Test, Residual, Wbc In Leukoreduced Blood|
|Applicant||Nanoentek, Inc. nanoentek, Inc. 851-14 Seohae-ro, Paltan-myeon 09 Hwaseong-si, 18531, KOREA, SOUTH|
|CFR Regulation Number||864.8625 [🔎]|
|Decision||Substantially Equivalent (SE)|
|3rd Party Reviewed||No|