The following data is part of a premarket notification filed by Phamatech with the FDA for Quick Screen Barbiturate Screening Test Models 9020 And 9021, Quick Screen Pro Multi Drug Screening Test Modl 9152.
| Device ID | K982152 |
| 510k Number | K982152 |
| Device Name: | QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-18 |
| Decision Date | 1998-09-21 |
| Summary: | summary |