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 |