The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Urine Drug Of Abuse Opiate Test (opium/heroin/morphine).
| Device ID | K952096 |
| 510k Number | K952096 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-04 |
| Decision Date | 1995-08-17 |