The following data is part of a premarket notification filed by Phamatech with the FDA for At Work Drug Test, Model 9145-25c; Model 9177-25c.
| Device ID | K994093 |
| 510k Number | K994093 |
| Device Name: | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C |
| Classification | Enzyme Immunoassay, Gentamicin |
| 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 | LCD |
| Subsequent Product Code | DIG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 1999-12-16 |
| Summary: | summary |