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FDA 4078 IVD electronic Submission Template and Resource (eSTAR)
Premarket Notification Submission 510(k), Subpart E
IVD eSTAR (static) FDA 4078
Premarket Notification Submissions
OMB: 0910-0120
OMB.report
HHS/FDA
OMB 0910-0120
ICR 202306-0910-007
IC 5734
FDA 4078 IVD electronic Submission Template and Resource (eSTAR)
( )
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0120 can be found here:
2023-08-28 - No material or nonsubstantive change to a currently approved collection
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File Title
IVD eSTAR v01.00.Static-2.pdf
Author
Lili.Duan
File Modified
2020-04-27
File Created
2020-03-02
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