Cleared Traditional

Distinct? Digital Pregnancy Test

K232715 · ACON Laboratories, Inc. · Chemistry
May 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K232715 is an FDA 510(k) clearance for the Distinct? Digital 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 May 31, 2024, 269 days after receiving the submission on September 5, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K232715 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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