K210341 is an FDA 510(k) clearance for the 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 Spd Swiss Precision Diagnostics GmbH (Geneva, CH). The FDA issued a Cleared decision on March 10, 2022, 398 days after receiving the submission on February 5, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K210341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2021 |
| Decision Date | March 10, 2022 |
| Days to Decision | 398 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 |