The following data is part of a premarket notification filed by Drial Consultants, Inc. with the FDA for Quickpac Ii One Step Marijuana (thc) Test.
| Device ID | K963207 |
| 510k Number | K963207 |
| Device Name: | QUICKPAC II ONE STEP MARIJUANA (THC) TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | DRIAL CONSULTANTS, INC. 1330 O'BRIEN DR. Menlo Park, CA 94025 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird DRIAL CONSULTANTS, INC. 1330 O'BRIEN DR. Menlo Park, CA 94025 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1997-02-20 |
| Summary: | summary |