The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Quickscreen Oxycodone Test, Models 9120, 9120t, 9120x And 9121.
| Device ID | K043051 |
| 510k Number | K043051 |
| Device Name: | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2005-02-07 |
| Summary: | summary |