The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen, Models 9177x And 9178x.
| Device ID | K041578 |
| 510k Number | K041578 |
| Device Name: | QUICKSCREEN, MODELS 9177X AND 9178X |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | PHAMATECH 10151 BARNES CANYON ROAD San Diego, CA 92121 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 10151 BARNES CANYON ROAD San Diego, CA 92121 |
| Product Code | LCM |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-09-10 |
| Summary: | summary |