The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071, 9076, 9081 And 9131.
| Device ID | K980865 |
| 510k Number | K980865 |
| Device Name: | QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Tuan Pham |
| Correspondent | Tuan Pham PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-06 |
| Decision Date | 1998-04-01 |