K241919 is an FDA 510(k) clearance for the Innovita HCG Pregnancy Rapid Combo Test. This device is classified as a Visual, Pregnancy Hcg, Prescription Use (Class II - Special Controls, product code JHI).
Submitted by Innovita (Tangshan) Biological Technology Co., Ltd. (Qian'An, CN). The FDA issued a Cleared decision on August 2, 2024, 32 days after receiving the submission on July 1, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K241919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | August 02, 2024 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| 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 |