The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for At Home Drug Test, Model 9079.
| Device ID | K013408 |
| 510k Number | K013408 |
| Device Name: | AT HOME DRUG TEST, MODEL 9079 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PHAMATECH INC. 9530 PADGETT ST., #101 San Diego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH INC. 9530 PADGETT ST., #101 San Diego, CA 92126 |
| Product Code | DJG |
| Subsequent Product Code | MVO |
| Subsequent Product Code | NGL |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-12-06 |
| Summary: | summary |