K232715 is an FDA 510(k) clearance for the Distinct® Digital Pregnancy Test. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on May 31, 2024, 269 days after receiving the submission on September 5, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K232715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2023 |
| Decision Date | May 31, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |