Submission Details
| 510(k) Number | K193318 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Distinct? Early Detection Pregnancy Test
Aug 2020
Decision
262d
Days
Class 2
Risk
About This 510(k) Submission
K193318 is an FDA 510(k) clearance for the Distinct? Early Detection Pregnancy Test, 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 review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
Manufacturer
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