The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen One Step Cocaine Screening Test (9070).
| Device ID | K972618 |
| 510k Number | K972618 |
| Device Name: | QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) |
| Classification | Thin Layer Chromatography, Cocaine |
| Applicant | PHAMATECH 9520 PADGETT ST. #108-110 San Diego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 9520 PADGETT ST. #108-110 San Diego, CA 92126 |
| Product Code | DMN |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-08-08 |
| Summary: | summary |