K212418 is an FDA 510(k) clearance for the hCG One Step Pregnancy Test. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Healstone Biotech, Inc. (Vancouver, CA). The FDA issued a Cleared decision on June 30, 2022, 331 days after receiving the submission on August 3, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K212418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2021 |
| Decision Date | June 30, 2022 |
| Days to Decision | 331 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 |