The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen One Step Thc Screening Test.
| Device ID | K973122 |
| 510k Number | K973122 |
| Device Name: | QUICKSCREEN ONE STEP THC SCREENING TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-20 |
| Decision Date | 1997-09-25 |
| Summary: | summary |