The following data is part of a premarket notification filed by Phamatech with the FDA for At Home Quickcup Pregnancy Test, Model 9015.
| Device ID | K993141 |
| 510k Number | K993141 |
| Device Name: | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-21 |
| Decision Date | 1999-11-08 |
| Summary: | summary |