The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen Methamphetamine Test, Models 9045, 9046, Quickscreen Pro Multi Drug Screening Test, Model 9225.
| Device ID | K000447 |
| 510k Number | K000447 |
| Device Name: | QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-10 |
| Decision Date | 2000-03-07 |