The following data is part of a premarket notification filed by Drial Consultants, Inc. with the FDA for One Step Urine Drug Of Abuse Methamphetamine Test.
| Device ID | K970265 |
| 510k Number | K970265 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | DRIAL CONSULTANTS, INC. 1445 LOS ANGELES AVE., SUITE 301P Simi Valley, CA 93065 |
| Contact | Cleve W Laird, Ph.d. |
| Correspondent | Cleve W Laird, Ph.d. DRIAL CONSULTANTS, INC. 1445 LOS ANGELES AVE., SUITE 301P Simi Valley, CA 93065 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-04-08 |
| Summary: | summary |