K213808 is an FDA 510(k) clearance for the Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 5, 2022, 120 days after receiving the submission on December 6, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K213808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2021 |
| Decision Date | April 05, 2022 |
| Days to Decision | 120 days |
| Submission Type | Special |
| 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 |