The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Quickscreen Amphetine 500 Test.
| Device ID | K131069 |
| 510k Number | K131069 |
| Device Name: | QUICKSCREEN AMPHETINE 500 TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-17 |
| Decision Date | 2014-05-14 |
| Summary: | summary |