FDA WARNING_LETTER - LumiQuick Diagnostics Inc. - December 07, 2012

FDA WARNING_LETTER for LumiQuick Diagnostics Inc. on December 07, 2012. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LumiQuick Diagnostics Inc. on December 07, 2012. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 352(t)(2)

21 CFR 803.17(a)

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

21 CFR 866.9

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(b)

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Record Information

Company

LumiQuick Diagnostics Inc.

Inspection Date

December 7, 2012

Product Type

Devices

Office

San Francisco District Office

People

ID: 33a06de0-cd77-46fb-9a72-25084471f3b6

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