Panels › Clinical Toxicology › Product code DKE · Class 2
Reagents, Test, Tetrahydrocannabinol
Regulation 862.3870
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DKE
| Company | 510(k)s | Recalls |
|---|---|---|
| Princeton BioMeditech Corp. | 4 | 0 |
| Marion Laboratories, Inc. | 2 | 0 |
| Medtox Diagnostics, Inc. | 2 | 0 |
| Alfa Scientific Designs, Inc. | 1 | 0 |
| Biochemical Diagnostic, Inc. | 1 | 0 |
| California Medical Developments, Inc. | 1 | 0 |
| Toxi-Lab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2000 | K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC Medtox Diagnostics, Inc. | DKE |
| Jun 2, 2000 | K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DKE |
| Jul 6, 1999 | K992068 | STATUS STIK, ACCUSIGN STIK Princeton BioMeditech Corp. | DKE |
| Jun 18, 1999 | K991751 | STATUS CUP ACCUSIGN CUP Princeton BioMeditech Corp. | DKE |
| Apr 15, 1999 | K991078 | 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 Princeton BioMeditech Corp. | DKE |
| Sep 28, 1998 | K983147 | 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 Princeton BioMeditech Corp. | DKE |
| Jul 29, 1998 | K982211 | PROFILE-II MODEL 600582 Medtox Diagnostics, Inc. | DKE |
| Jun 1, 1990 | K901694 | SPEC(TM) EXTRACTION CARTRIDGE Toxi-Lab, Inc. | DKE |
| Jul 5, 1988 | K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN Marion Laboratories, Inc. | DKE |
| Jul 6, 1984 | K841831 | CANNU-SKREEN-PRELIMINARY Biochemical Diagnostic, Inc. | DKE |
| Jun 30, 1983 | K831456 | TOXI-LAB CANNABINOID THC SCREEN Marion Laboratories, Inc. | DKE |
| Feb 29, 1980 | K792282 | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG California Medical Developments, Inc. | DKE |
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