FDA 510(k) Applications for Medical Device Product Code "DKE"
(Reagents, Test, Tetrahydrocannabinol)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K994405 |
ALFA SCIENTIFIC DESIGNS, INC. |
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST |
06/02/2000 |
K982211 |
MEDTOX DIAGNOSTICS, INC. |
PROFILE-II MODEL 600582 |
07/29/1998 |
K003687 |
MEDTOX DIAGNOSTICS, INC. |
VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC |
12/22/2000 |
K983147 |
PRINCETON BIOMEDITECH CORP. |
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P |
09/28/1998 |
K991078 |
PRINCETON BIOMEDITECH CORP. |
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 |
04/15/1999 |
K991751 |
PRINCETON BIOMEDITECH CORP. |
STATUS CUP ACCUSIGN CUP |
06/18/1999 |
K992068 |
PRINCETON BIOMEDITECH CORP. |
STATUS STIK, ACCUSIGN STIK |
07/06/1999 |
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