The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Modified Labeling For Toxi-lab Thc Screen.
| Device ID | K875182 |
| 510k Number | K875182 |
| Device Name: | MODIFIED LABELING FOR TOXI-LAB THC SCREEN |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | Guinty, Jr |
| Correspondent | Guinty, Jr MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | DKE |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-07-05 |