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Warning Letter

Case 392748 — FEI 3005984081

Facility

Recent inspections

  • 1295738 (NAI Wed Nov 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949462 (NAI Tue Nov 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935468 (VAI Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867537 (NAI Mon Feb 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 809900 (OAI Fri Dec 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
LumiQuick Diagnostics Inc.
Date
July 31, 2013
Fiscal Year
2013
Product Type
Devices
Center
CDRH
Location
Santa Clara, CA (United States)