K232864 is an FDA 510(k) clearance for the EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Nantong Egens Biotechnology Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on January 26, 2024, 133 days after receiving the submission on September 15, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K232864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2023 |
| Decision Date | January 26, 2024 |
| Days to Decision | 133 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 |