LumiQuick Diagnostics Inc.

FDA Regulatory Profile

Summary

Total Recalls
80
510(k) Clearances
1
Inspections
5
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1392-2014Class IIKetamine Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1402-2014Class IIMethylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1403-2014Class IIFentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1381-2014Class IIMethadone Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1350-2014Class IIMalaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1412-2014Class IICardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1401-2014Class IIMethylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1396-2014Class IIOxycodone Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1368-2014Class IIAmphetamine Strip; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1364-2014Class IIAlcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1414-2014Class IIMyoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1369-2014Class IIAmphetamine Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1359-2014Class IIDengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1366-2014Class IITramadol Strip; LumiQuick. Santa Clara, CA 95054March 4, 2014
Z-1343-2014Class IISalmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1391-2014Class IITHC Test Card; LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1384-2014Class IIMorphine Strip (300); LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1344-2014Class IIRotavirus Test Card LumiQuick, Santa Clara, CA 95054March 4, 2014
Z-1416-2014Class IICK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054March 4, 2014
Z-1407-2014Class IIK2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054March 4, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICEOctober 18, 2013