The following data is part of a premarket notification filed by Phamatech with the FDA for Quickstick Pro Hcg Test.
| Device ID | K974615 |
| 510k Number | K974615 |
| Device Name: | QUICKSTICK PRO HCG TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-11 |
| Decision Date | 1998-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028181 | K974615 | 000 |