The following data is part of a premarket notification filed by Drial Consultants, Inc. with the FDA for Quikstrip One Step Opiates Test.
| Device ID | K972571 |
| 510k Number | K972571 |
| Device Name: | QUIKSTRIP ONE STEP OPIATES TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | DRIAL CONSULTANTS, INC. 1420 LOS ANGELES AVE. STE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird DRIAL CONSULTANTS, INC. 1420 LOS ANGELES AVE. STE 201 Simi Valley, CA 93065 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-08-20 |
| Summary: | summary |