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LumiQuick Diagnostics Inc.

FDA Regulatory Profile

LumiQuick Diagnostics Inc. appears in FDA public data with 80 recalls, 1 510(k) clearance, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1402-2014, Class II) was initiated on March 4, 2014. Its most recent 510(k) clearance was granted on October 18, 2013.

Summary

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

Recent Recalls

Number	Class	Product	Date
Z-1402-2014	Class II	Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1387-2014	Class II	Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054	March 4, 2014
Z-1373-2014	Class II	Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054	March 4, 2014
Z-1392-2014	Class II	Ketamine Strip; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1401-2014	Class II	Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1406-2014	Class II	Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1366-2014	Class II	Tramadol Strip; LumiQuick. Santa Clara, CA 95054	March 4, 2014
Z-1344-2014	Class II	Rotavirus Test Card LumiQuick, Santa Clara, CA 95054	March 4, 2014
Z-1411-2014	Class II	Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1359-2014	Class II	Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054	March 4, 2014
Z-1343-2014	Class II	Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054	March 4, 2014
Z-1391-2014	Class II	THC Test Card; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1384-2014	Class II	Morphine Strip (300); LumiQuick, Santa Clara, CA 95054	March 4, 2014
Z-1416-2014	Class II	CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1394-2014	Class II	Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1398-2014	Class II	Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1370-2014	Class II	Barbiturate Strip; LumiQuick. Santa Clara, CA 95054	March 4, 2014
Z-1369-2014	Class II	Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054	March 4, 2014
Z-1407-2014	Class II	K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054	March 4, 2014
Z-1385-2014	Class II	Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054	March 4, 2014

Recent 510(k) Clearances

K-Number	Device	Date
K130213	QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE	October 18, 2013

LumiQuick Diagnostics Inc.

Summary

Recent Recalls

Recent 510(k) Clearances

FDA data resources