The following data is part of a premarket notification filed by Phamatech with the FDA for Modification To At Home Drug Test, Models 9150, 9068, And 9175.
| Device ID | K003858 |
| 510k Number | K003858 |
| Device Name: | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | PHAMATECH 9520 PADGETT ST. #101 San Diego, CA 92126 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH 9520 PADGETT ST. #101 San Diego, CA 92126 |
| Product Code | MVO |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-13 |
| Decision Date | 2001-02-12 |