FDA WARNING_LETTER - USH Diagnostics, Inc./covidinstanttest.net - April 09, 2021

FDA WARNING_LETTER for USH Diagnostics, Inc./covidinstanttest.net on April 09, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for USH Diagnostics, Inc./covidinstanttest.net on April 09, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

21 U.S.C. 352(a)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360bbb-3

21 U.S.C. 360e(a)

21 U.S.C. 352(o)

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Record Information

Company

USH Diagnostics, Inc./covidinstanttest.net

Inspection Date

April 9, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy T. Stenzel (Director)

ID: ed292823-09a6-4c20-ab67-be7bc0db5b60

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