The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen One Step Opiate Screening Test (9080).
| Device ID | K972619 |
| 510k Number | K972619 |
| Device Name: | QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-08-20 |
| Summary: | summary |