K212447 is an FDA 510(k) clearance for the SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Hangzhou Sejoy Electronics & Instruments Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on February 18, 2022, 197 days after receiving the submission on August 5, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K212447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2021 |
| Decision Date | February 18, 2022 |
| Days to Decision | 197 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 |