The following data is part of a premarket notification filed by Phamatech with the FDA for Quickstick One Step Pregnancy Test(9010).
| Device ID | K962219 |
| 510k Number | K962219 |
| Device Name: | QUICKSTICK ONE STEP PREGNANCY TEST(9010) |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Contact | Tuan Pham |
| Correspondent | Tuan Pham PHAMATECH 9265 ACTIVITY RD. SUITE 112-113 Sandiego, CA 92126 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-10 |
| Decision Date | 1996-07-23 |
| Summary: | summary |