Atlas FDA

MVO

18 FDA 510(k) clearances · Product code

52 daysmedian time to decision
153 days90th percentile
18clearances measured

FDA profile

Official device name
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2005: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) (K040327)Accu-Stat Diagnostics, Inc.2004-04-19
AT HOME DRUG CUP, MODEL 9150X (K030447)Phamatech2003-04-14
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET (K014192)Princeton BioMeditech Corp.2002-05-23
PEACE OF MIND HOME DRUG TEST (K013778)Advantage Diagnostics Corp.2002-02-07
AT HOME DRUG TEST, MODEL 9074 (K013409)Phamatech, Inc.2001-12-06
AT HOME DRUG TEST, MODEL 9064 (K013410)Phamatech, Inc.2001-12-06
AT HOME DRUG TEST, MODEL 9069 (K013412)Phamatech, Inc.2001-12-06
AT HOME DRUG TESTT, MODEL 9150 T (K010655)Phamatech2001-04-05
AT HOME DRUG TEST, MODEL 9078 T (K010654)Phamatech2001-04-05
AT HOME DRUG TEST, MODEL 9068 T (K010653)Phamatech2001-04-05
AT HOME DRUG TEST, MODEL 9083 T (K010646)Phamatech2001-03-30
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 (K003858)Phamatech2001-02-12
DRUG STOP (K991465)Texas Immunology, Inc.1999-12-10
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C (K992685)Phamatech1999-10-06
AT HOME DRUG TEST, MODEL 9175 (K992217)Phamatech1999-07-13
AT HOME DRUG TEST, MODEL 9171 (K991824)Phamatech1999-06-11
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 (K991641)Phamatech1999-06-01
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 (K982621)Phamatech1998-10-16

Track MVO automatically

Every clearance here is in the API, with alerts when new ones post.