MVO — Kit, Test, Multiple, Drugs Of Abuse, Over The Counter Class U

FDA Device Classification

Classification Details

Product Code
MVO
Device Class
Class U
Regulation Number
Submission Type
Review Panel
TX
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040327accu-stat diagnosticsACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, April 19, 2004
K030447phamatechAT HOME DRUG CUP, MODEL 9150XApril 14, 2003
K014192princeton biomeditechLIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STMay 23, 2002
K013778advantage diagnosticsPEACE OF MIND HOME DRUG TESTFebruary 7, 2002
K013412phamatechAT HOME DRUG TEST, MODEL 9069December 6, 2001
K013410phamatechAT HOME DRUG TEST, MODEL 9064December 6, 2001
K013409phamatechAT HOME DRUG TEST, MODEL 9074December 6, 2001
K010653phamatechAT HOME DRUG TEST, MODEL 9068 TApril 5, 2001
K010654phamatechAT HOME DRUG TEST, MODEL 9078 TApril 5, 2001
K010655phamatechAT HOME DRUG TESTT, MODEL 9150 TApril 5, 2001
K010646phamatechAT HOME DRUG TEST, MODEL 9083 TMarch 30, 2001
K003858phamatechMODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175February 12, 2001
K991465texas immunologyDRUG STOPDecember 10, 1999
K992685phamatechQUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25COctober 6, 1999
K992217phamatechAT HOME DRUG TEST, MODEL 9175July 13, 1999
K991824phamatechAT HOME DRUG TEST, MODEL 9171June 11, 1999
K991641phamatechAT HOME COCAINE & THC SCREENING TEST, MODEL 9170June 1, 1999
K982621phamatechQUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150October 16, 1998