Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test

K-Number: K142754 · 2016-04-07

ApplicantSugentech, Inc.
Decision Date2016-04-07
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test is a medical device manufactured by Sugentech, Inc.. It received FDA 510(k) clearance on 2016-04-07 under approval number K142754. 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 Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test?

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Sugentech, Inc.. The 510(k) number is K142754.

When was Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test approved by the FDA?

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test received FDA 510(k) clearance on 2016-04-07, under approval number K142754.

What company makes Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test?

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test is manufactured by Sugentech, Inc..

What is the FDA product code for Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test?

The FDA product code for Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test is LCX.

Related Clinical Trials

NCT07566793 Validation of Effectiveness on NaturalCycles Users RECRUITING NCT06647511 Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women RECRUITING NCT06615843 Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up RECRUITING

Related Devices (Code: LCX)

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. 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.

↑