Decision Date2017-11-20
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
LIA Pregnancy Test is a medical device manufactured by Lia Diagnostics. It received FDA 510(k) clearance on 2017-11-20 under approval number K171136. 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 LIA Pregnancy Test?
LIA Pregnancy Test is a medical device that received FDA 510(k) clearance on 2017-11-20. It is manufactured by Lia Diagnostics. The 510(k) number is K171136.
When was LIA Pregnancy Test approved by the FDA?
LIA Pregnancy Test received FDA 510(k) clearance on 2017-11-20, under approval number K171136.
What company makes LIA Pregnancy Test?
LIA Pregnancy Test is manufactured by Lia Diagnostics.
What is the FDA product code for LIA Pregnancy Test?
The FDA product code for LIA Pregnancy Test is LCX.
Related Devices (Code: LCX)
K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc.
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.