The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Toxi-lab Cannabinoid Thc Screen.
| Device ID | K831456 |
| 510k Number | K831456 |
| Device Name: | TOXI-LAB CANNABINOID THC SCREEN |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DKE |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-06 |
| Decision Date | 1983-06-30 |