ClearanceBrief
Panels › Clinical Chemistry › Product code LCX · Class 2

Kit, Test, Pregnancy, Hcg, Over The Counter

Regulation 862.1155

0510(k)s in 12 months (226 all time)
2recalls in 12 months (25 all time)
16recalls that name a 510(k)
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Top companies in LCX

Company510(k)sRecalls
Unipath , Ltd.200
ACON Laboratories, Inc.100
Armkel, LLC100
Quidel Corp.90
Family Dollar Stores, Llc.07
Mizuho USA, Inc.51
Syntron Bioresearch, Inc.60
Advanced Care Products50
Church & Dwight Co., Inc.41
Phamatech50
Decided510(k)Device and applicantCode
Sep 9, 2025K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
Guangzhou Decheng Biotechnology Co., Ltd., CN
LCX
Jul 15, 2025K251053Shinetell PlusTM Digital Early Pregnancy Test
Hangzhou AllTest Biotech Co., Ltd., CN
LCX
Feb 13, 2025K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Assure Tech., LLC
LCX
Jan 31, 2025K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
Nanjing Synthgene Medical Technology Co., Ltd., CN
LCX
Jan 15, 2025K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test M
Assure Tech., LLC
LCX
Dec 20, 2024K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Andon Health Co, Ltd., CN
LCX
Oct 11, 2024K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use
Anhui Deepblue Medical Technology Co., Ltd., CN
LCX
Aug 13, 2024K241978Shinetell Digital Pregnancy Test
Hangzhou AllTest Biotech Co., Ltd., CN
LCX
Jun 21, 2024K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detectio
Guangzhou Decheng Biotechnology Co., Ltd., CN
LCX
May 31, 2024K232715Distinct® Digital Pregnancy Test
ACON Laboratories, Inc.
LCX
Apr 12, 2024K233624HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC,
Hangzhou Aichek Medical Technology Co., Ltd., CN
LCX
Apr 5, 2024K234152ACESO Early Pregnancy Test
Aceso Laboratories, Inc.
LCX
Feb 5, 2024K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream
Assure Tech. (Hangzhou) Co, Ltd., CN
LCX
Jan 31, 2024K240025Clearblue® Early Detection Pregnancy Test
Spd Swiss Precision Diagnostics GmbH, CH
LCX
Jan 26, 2024K232864EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Nantong Egens Biotechnology Co., Ltd., CN
LCX
Oct 13, 2023K230741Macro & Micro-Test HCG Pregnancy Test Midstream
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., CN
LCX
Feb 28, 2023K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Guangzhou Decheng Biotechnology Co., Ltd., CN
LCX
Nov 30, 2022K222305MissLan™ Digital Pregnancy Rapid Test
Guangzhou Decheng Biotechnology Co., Ltd., CN
LCX
Sep 21, 2022K213379Clearblue ® Early Pregnancy Test
Spd Swiss Precision Diagnostics GmbH, CH
LCX
Jun 30, 2022K212418hCG One Step Pregnancy Test
Healstone Biotech, Inc., CA
LCX
Apr 5, 2022K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropi
Co-Innovation Biotech Co., Ltd., CN
LCX
Mar 10, 2022K210341One Step Pregnancy Test
Spd Swiss Precision Diagnostics GmbH, CH
LCX
Feb 18, 2022K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test M
Hangzhou Sejoy Electronics & Instruments Co., Ltd., CN
LCX
Aug 13, 2021K200913Clearblue® Early Digital Pregnancy Test
Spd Swiss Precision Diagnostics GmbH, CH
LCX
Aug 4, 2021K203246Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG
Atlas Link Technology Co., Ltd., CN
LCX
Aug 20, 2020K193318Distinct® Early Detection Pregnancy Test
ACON Laboratories, Inc.
LCX
Aug 13, 2020K200133hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
Safecare Biotech (Hangzhou) Co., Ltd., CN
LCX
Dec 11, 2019K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test M
Hangzhou Clongene Biotech Co., Ltd., CN
LCX
Nov 22, 2019K192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test M
Innovita (Tangshan) Biological Technology Co., Ltd., CN
LCX
Sep 5, 2019K192123HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
Qingdao Hightop Biotech Co., Ltd., CN
LCX
May 15, 2019K182328VeriClear Digital Early Result Pregnancy Test
True Diagnostics, Inc.
LCX
Apr 15, 2019K190705WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstre
Wholepower Biotech Co., Ltd., CN
LCX
Feb 22, 2019K181551DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescript
Runbio Biotech Co.,Ltd, CN
LCX
Jan 10, 2019K183097Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
Weihai Kangzhou Biotechnology Engineering Co., Ltd., CN
LCX
May 18, 2018K180771Acro HCG Pregnancy Rapid Test
Acro Biotech, Inc.
LCX
Mar 28, 2018K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Runbio Biotech Co.,Ltd, CN
LCX
Mar 12, 2018K173229Preview Digital Pregnancy Test
Guangzhou Wondfo Biotech Co., Ltd., CN
LCX
Feb 2, 2018K172512ACRO HCG Pregnancy Rapid Test
Acro Biotech, Inc.
LCX
Nov 20, 2017K171136LIA Pregnancy Test
Lia Diagnostics
LCX
Apr 7, 2016K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Sugentech, Inc., KR
LCX
Oct 2, 2015K150063One Step hCG Pregnancy Test
Coretests, Inc.
LCX
Aug 7, 2015K150022Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG U
Guangzhou Wondfo Biotech Co., Ltd., CN
LCX
Nov 12, 2013K132085ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
Co-Innovation Biotech Co., Ltd., CN
LCX
Nov 7, 2013K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
Ucp Biosciences, Inc.
LCX
Sep 10, 2013K123567FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
Church & Dwight Co., Inc.
LCX
Aug 26, 2013K123436FIRST RESPONSE EARLY RESULT PREGNANCY TEST
Church & Dwight Co., Inc.
LCX
Jul 26, 2013K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
Chemtron Biotech, Inc.
LCX
Apr 10, 2013K123703HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
Healgen Scientific,, LLC
LCX
Mar 14, 2013K122907FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
Polymed Therapeutics, Inc.
LCX
Feb 5, 2013K123050EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
Nantong Biotechnology Co., Ltd.
LCX

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