The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Urine Drug Of Abuse: Benzodiazepine Test.
| Device ID | K980776 |
| 510k Number | K980776 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | TCPI, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird TCPI, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-04-29 |
| Summary: | summary |