Cleared Traditional

VeriClear Digital Early Result Pregnancy Test

K182328 · True Diagnostics, Inc. · Chemistry
May 2019
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K182328 is an FDA 510(k) clearance for the VeriClear Digital Early Result Pregnancy Test, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by True Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 15, 2019, 261 days after receiving the submission on August 27, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K182328 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2018
Decision Date May 15, 2019
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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