Product code DKE
- Device name
- Reagents, Test, Tetrahydrocannabinol
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3870
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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. | 2000-12-22 |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-06-02 |
| K992068 | STATUS STIK, ACCUSIGN STIK | Princeton BioMeditech Corp. | 1999-07-06 |
| K991751 | STATUS CUP ACCUSIGN CUP | Princeton BioMeditech Corp. | 1999-06-18 |
| 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. | 1999-04-15 |
| 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. | 1998-09-28 |
| K982211 | PROFILE-II MODEL 600582 | Medtox Diagnostics, Inc. | 1998-07-29 |
| K901694 | SPEC(TM) EXTRACTION CARTRIDGE | Toxi-Lab, Inc. | 1990-06-01 |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Marion Laboratories, Inc. | 1988-07-05 |
| K841831 | CANNU-SKREEN-PRELIMINARY | Biochemical Diagnostic, Inc. | 1984-07-06 |
| K831456 | TOXI-LAB CANNABINOID THC SCREEN | Marion Laboratories, Inc. | 1983-06-30 |
| K792282 | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG | California Medical Developments, Inc. | 1980-02-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10694644200161 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200307 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200291 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200284 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200277 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200260 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200253 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200246 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200239 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200222 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200215 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200208 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200192 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200185 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200178 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200017 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200154 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200147 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200130 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200123 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200116 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200109 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200093 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200086 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200079 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200062 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200055 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200048 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200031 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |
| 10694644200024 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | 2016-09-23 |