The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen Benzodiazepines Screening Test Model Numbers 9025,9026 And Quickscreen Pro Multi Drug Screening Test Model 1.
| Device ID | K981687 |
| 510k Number | K981687 |
| Device Name: | QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| 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 | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-13 |
| Decision Date | 1998-06-03 |
| Summary: | summary |