The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Pnc100 Digital Pregancy Test, Td-5301 Pregancy Test.
| Device ID | K103487 |
| 510k Number | K103487 |
| Device Name: | FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, NO.127 WUGONG 2ND RD, WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-10-04 |
| Summary: | summary |