FDA WARNING_LETTER - EnMed MicroAnalytics, Inc. - March 02, 2021

FDA WARNING_LETTER for EnMed MicroAnalytics, Inc. on March 02, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for EnMed MicroAnalytics, Inc. on March 02, 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. 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

EnMed MicroAnalytics, Inc.

Inspection Date

March 2, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: 70980a97-b3c6-4bea-8979-e81a51ce4aa7

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