The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Quickscreen Cocaine 150 Screening Test.
| Device ID | K103295 |
| 510k Number | K103295 |
| Device Name: | QUICKSCREEN COCAINE 150 SCREENING TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-08 |
| Decision Date | 2012-02-01 |
| Summary: | summary |