FDA WARNING_LETTER - KBMO Diagnostics, LLC - June 16, 2020

FDA WARNING_LETTER for KBMO Diagnostics, LLC on June 16, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for KBMO Diagnostics, LLC on June 16, 2020. 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. 360e(a)

21 U.S.C. 352(o)

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Record Information

Company

KBMO Diagnostics, LLC

Inspection Date

June 16, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: edf4ba5a-0f82-4b23-b0d6-83be0ad0dca7

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