The following data is part of a premarket notification filed by Biochemical Diagnostic, Inc. with the FDA for Cannu-skreen-preliminary.
| Device ID | K841831 |
| 510k Number | K841831 |
| Device Name: | CANNU-SKREEN-PRELIMINARY |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | BIOCHEMICAL DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKE |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-03 |
| Decision Date | 1984-07-06 |