K102175 is an FDA 510(k) clearance for the RAPIDVUE HCG TEST. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on August 25, 2010, 23 days after receiving the submission on August 2, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K102175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2010 |
| Decision Date | August 25, 2010 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHI — Visual, Pregnancy Hcg, Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |