DKE — Reagents, Test, Tetrahydrocannabinol Class II
FDA product code DKE covers "Reagents, Test, Tetrahydrocannabinol", a Class II medical device regulated under 21 CFR 862.3870. Submissions are reviewed by the Clinical Toxicology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DKE
- Device Class
- Class II
- Regulation Number
- 862.3870
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003687 | medtox diagnostics | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT | December 22, 2000 |
| K994405 | alfa scientific designs | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | June 2, 2000 |
| K992068 | princeton biomeditech | STATUS STIK, ACCUSIGN STIK | July 6, 1999 |
| K991751 | princeton biomeditech | STATUS CUP ACCUSIGN CUP | June 18, 1999 |
| K991078 | princeton biomeditech | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OP | April 15, 1999 |
| K983147 | princeton biomeditech | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, | September 28, 1998 |
| K982211 | medtox diagnostics | PROFILE-II MODEL 600582 | July 29, 1998 |
| K901694 | toxi-lab | SPEC(TM) EXTRACTION CARTRIDGE | June 1, 1990 |
| K875182 | marion laboratories | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | July 5, 1988 |
| K841831 | biochemical diagnostic | CANNU-SKREEN-PRELIMINARY | July 6, 1984 |
| K831456 | marion laboratories | TOXI-LAB CANNABINOID THC SCREEN | June 30, 1983 |
| K792282 | california medical developments | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG | February 29, 1980 |