The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Drug Check.
| Device ID | K980153 |
| 510k Number | K980153 |
| Device Name: | DRUG CHECK |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 Tyler, TX 75707 |
| Contact | Charles W Gill |
| Correspondent | Charles W Gill TEXAS IMMUNOLOGY, INC. 5400 SPUR 248 Tyler, TX 75707 |
| Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | DPK |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-03-27 |