The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Verdict Ii Thc/coc/opi/amp, Verdictii Thc/coc/opi,verdict Ii Thc/coc/amp,verdict Ii Thc/coc/pcp,verdict Ii Thc/coc.
| Device ID | K003687 |
| 510k Number | K003687 |
| Device Name: | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Contact | Michael Turanchik |
| Correspondent | Michael Turanchik MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215 |
| Product Code | DKE |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-30 |
| Decision Date | 2000-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10690286000244 | K003687 | 000 |
| 10690286000145 | K003687 | 000 |
| 00690286000131 | K003687 | 000 |
| 00690286000124 | K003687 | 000 |
| 00690286000117 | K003687 | 000 |
| 00690286000100 | K003687 | 000 |