The following data is part of a premarket notification filed by James Nguyen with the FDA for Wunder Pregnancy Test.
| Device ID | K130456 |
| 510k Number | K130456 |
| Device Name: | WUNDER PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | JAMES NGUYEN 2231 FORTUNE DR, STE D San Jose, CA 95131 |
| Contact | James Nguyen, M.d. |
| Correspondent | James Nguyen, M.d. JAMES NGUYEN 2231 FORTUNE DR, STE D San Jose, CA 95131 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2014-04-08 |
| Summary: | summary |