The following data is part of a premarket notification filed by Phamatech with the FDA for Quick Screen One Step Amphetamine Test.
| Device ID | K972577 |
| 510k Number | K972577 |
| Device Name: | QUICK SCREEN ONE STEP AMPHETAMINE TEST |
| Classification | Thin Layer Chromatography, 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 | DIT |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-08-20 |
| Summary: | summary |