The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen Pro Drug Cup, Model 9195x.
| Device ID | K001397 |
| 510k Number | K001397 |
| Device Name: | QUICKSCREEN PRO DRUG CUP, MODEL 9195X |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-03 |
| Decision Date | 2000-05-26 |