FDA 510(k) Applications for Medical Device Product Code "MVO"
(Kit, Test, Multiple, Drugs Of Abuse, Over The Counter)

FDA 510(k) Number Applicant Device Name Decision Date
K040327 ACCU-STAT DIAGNOSTICS, INC. ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) 04/19/2004
K013778 ADVANTAGE DIAGNOSTICS CORP. PEACE OF MIND HOME DRUG TEST 02/07/2002
K991641 PHAMATECH AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 06/01/1999
K030447 PHAMATECH AT HOME DRUG CUP, MODEL 9150X 04/14/2003
K010653 PHAMATECH AT HOME DRUG TEST, MODEL 9068 T 04/05/2001
K010654 PHAMATECH AT HOME DRUG TEST, MODEL 9078 T 04/05/2001
K010646 PHAMATECH AT HOME DRUG TEST, MODEL 9083 T 03/30/2001
K991824 PHAMATECH AT HOME DRUG TEST, MODEL 9171 06/11/1999
K992217 PHAMATECH AT HOME DRUG TEST, MODEL 9175 07/13/1999
K010655 PHAMATECH AT HOME DRUG TESTT, MODEL 9150 T 04/05/2001
K003858 PHAMATECH MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 02/12/2001
K982621 PHAMATECH QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 10/16/1998
K992685 PHAMATECH QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C 10/06/1999
K013410 PHAMATECH INC. AT HOME DRUG TEST, MODEL 9064 12/06/2001
K013412 PHAMATECH INC. AT HOME DRUG TEST, MODEL 9069 12/06/2001
K013409 PHAMATECH INC. AT HOME DRUG TEST, MODEL 9074 12/06/2001
K014192 PRINCETON BIOMEDITECH CORP. LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET 05/23/2002
K991465 TEXAS IMMUNOLOGY, INC. DRUG STOP 12/10/1999


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