FDA WARNING_LETTER - Medakit Ltd - June 06, 2020

FDA WARNING_LETTER for Medakit Ltd on June 06, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Medakit Ltd on June 06, 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. 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

Medakit Ltd

Inspection Date

June 6, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: ad1bafd4-53e7-41b0-b6b7-c6dda6ea5dfa

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