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Office of In Vitro Diagnostic Devices

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Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

The CeSub eSubmitter software may be used to submit premarket notification applications, 510(k)s, for In Vitro Diagnostic Devices reviewed at OIVD. Currently, the software supports both “bundled” and single applications for all traditional, abbreviated, and special 510(k)s including:

  • Antimicrobial Susceptibility Testing (AST) Devices
  • All Other In Vitro Device Types

Additional submissions and updates are currently under development and will be available on a continuous basis. Please periodically check the OIVD homepage at http://www.fda.gov/cdrh/oivd/ for more information.

Updated February 6, 2008

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Center for Devices and Radiological Health / CDRH