K193318 is an FDA 510(k) clearance for the Distinct® Early Detection 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 August 20, 2020, 262 days after receiving the submission on December 2, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K193318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2019 |
| Decision Date | August 20, 2020 |
| Days to Decision | 262 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 |