The following data is part of a premarket notification filed by Phamatech with the FDA for Quickcard Hcg Combo Test, Model #9014.
| Device ID | K991095 |
| 510k Number | K991095 |
| Device Name: | QUICKCARD HCG COMBO TEST, MODEL #9014 |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-04-28 |
| Summary: | summary |