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FDA 510(k)

Preview Digital Pregnancy Test

K-Number: K173229 · 2018-03-12

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2018-03-12
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Preview Digital Pregnancy Test is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-03-12 under approval number K173229. 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 Preview Digital Pregnancy Test?

Preview Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2018-03-12. It is manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K173229.

When was Preview Digital Pregnancy Test approved by the FDA?

Preview Digital Pregnancy Test received FDA 510(k) clearance on 2018-03-12, under approval number K173229.

What company makes Preview Digital Pregnancy Test?

Preview Digital Pregnancy Test is manufactured by Guangzhou Wondfo Biotech Co., Ltd..

What is the FDA product code for Preview Digital Pregnancy Test?

The FDA product code for Preview Digital Pregnancy Test is LCX.

Related Clinical Trials

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Related PubMed Literature

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)

Other Devices by Guangzhou Wondfo Biotech Co., Ltd.

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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 K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc. K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test MidstreamHangzhou Clongene Biotech Co., Ltd.

Official Source

View on FDA Database →

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

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