The following data is part of a premarket notification filed by Drial Consultants, Inc. with the FDA for One Step Urine Drug Of Abuse Barbiturate Test.
| Device ID | K973047 |
| 510k Number | K973047 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-15 |
| Decision Date | 1997-10-02 |
| Summary: | summary |