The following data is part of a premarket notification filed by Phamatech with the FDA for Quick Card Hcg One Step Pregnancy Test.
| Device ID | K973570 |
| 510k Number | K973570 |
| Device Name: | QUICK CARD HCG ONE STEP PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-10-31 |
| Summary: | summary |