The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen Pro Multi Drug Screen, Model 9177 & 9178.
| Device ID | K993165 |
| 510k Number | K993165 |
| Device Name: | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCL |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-22 |
| Decision Date | 1999-10-20 |
| Summary: | summary |