The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Urine Drug Of Abuse Cocaine Test.
| Device ID | K951892 |
| 510k Number | K951892 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE COCAINE TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Contact | Clece W Laird |
| Correspondent | Clece W Laird TCPI, INC. 3341 S.W. 15TH ST. Pompano Beach, FL 33069 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-08-17 |