FDA 510(k)

VeriClear Digital Early Result Pregnancy Test

K-Number: K182328 · 2019-05-15

Decision Date2019-05-15

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VeriClear Digital Early Result Pregnancy Test is a medical device manufactured by True Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-05-15 under approval number K182328. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VeriClear Digital Early Result Pregnancy Test?

VeriClear Digital Early Result Pregnancy Test is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by True Diagnostics, Inc.. The 510(k) number is K182328.

When was VeriClear Digital Early Result Pregnancy Test approved by the FDA?

VeriClear Digital Early Result Pregnancy Test received FDA 510(k) clearance on 2019-05-15, under approval number K182328.

What company makes VeriClear Digital Early Result Pregnancy Test?

VeriClear Digital Early Result Pregnancy Test is manufactured by True Diagnostics, Inc..

What is the FDA product code for VeriClear Digital Early Result Pregnancy Test?

The FDA product code for VeriClear Digital Early Result Pregnancy Test is LCX.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026) PMID: 41032887 Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study. Journal of medical Internet research (2025) PMID: 40380731 Effective Requirements Engineering in Early-Stage Digital Health Startups. Studies in health technology and informatics (2025)

Other Devices by True Diagnostics, Inc.

K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.