FDA WARNING_LETTER - RadLogics, Inc. - Unknown Date

FDA WARNING_LETTER for RadLogics, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for RadLogics, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 321(h)

21 CFR 884.2980(a)

21 U.S.C. 360(k)

21 CFR 807.100

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

21 CFR 807.81(a)(3)(ii)

21 U.S.C. 360c(i)(1)

21 CFR 807.81(b)

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Record Information

Company

RadLogics, Inc.

Inspection Date

Unknown Date

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Donald St. Pierre

ID: 2911bd28-11f8-4610-9a50-ec7b37a45ca5

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