The following data is part of a premarket notification filed by California Medical Developments, Inc. with the FDA for Drugalyzer Dtk-1000 Kit Presumptive Drug.
| Device ID | K792282 |
| 510k Number | K792282 |
| Device Name: | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG |
| Classification | Reagents, Test, Tetrahydrocannabinol |
| Applicant | CALIFORNIA MEDICAL DEVELOPMENTS, 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 | 1979-11-13 |
| Decision Date | 1980-02-29 |