The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Quickscreen Pro Multi Drug Screening Test, Model 9395z.
| Device ID | K181945 |
| 510k Number | K181945 |
| Device Name: | QuickScreen Pro Multi Drug Screening Test, Model 9395Z |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Phamatech Inc. 15175 Innovation Drive San Diego, CA 92128 |
| Contact | Robert Merlock |
| Correspondent | Korina A. Akhondzadeh Kara & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-20 |
| Decision Date | 2018-10-18 |
| Summary: | summary |