The following data is part of a premarket notification filed by Phamatech with the FDA for Quick Screen Methadone Screening Test, Models 9035, 9036, Quick Screen Pro Multi Drug Screening Test Model 9153.
| Device ID | K982938 |
| 510k Number | K982938 |
| Device Name: | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Tuan Pham |
| Correspondent | Tuan Pham PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1999-02-05 |
| Summary: | summary |