K103487 is an FDA 510(k) clearance for the FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on October 4, 2011, 312 days after receiving the submission on November 26, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K103487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2010 |
| Decision Date | October 04, 2011 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |