LCX · Class II · 21 CFR 862.1155

FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Leading manufacturers include Unipath , Ltd., ACON Laboratories, Inc. and Armkel, LLC.

226
Total
226
Cleared
104d
Avg days
1978
Since
226 devices
25–48 of 226
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
K203246
Atlas Link Technology Co., Ltd.
Chemistry · 273d
Cleared Aug 20, 2020
Distinct® Early Detection Pregnancy Test
K193318
ACON Laboratories, Inc.
Chemistry · 262d
Cleared Aug 13, 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
K200133
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 205d
Cleared Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream
K193132
Hangzhou Clongene Biotech Co., Ltd.
Chemistry · 29d
Cleared Nov 22, 2019
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream
K192843
Innovita (Tangshan) Biological Technology Co., Ltd.
Chemistry · 50d
Cleared Sep 05, 2019
HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream
K192123
Qingdao Hightop Biotech Co., Ltd.
Chemistry · 30d
Cleared May 15, 2019
VeriClear Digital Early Result Pregnancy Test
K182328
True Diagnostics, Inc.
Chemistry · 261d
Cleared Apr 15, 2019
WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
K190705
Wholepower Biotech Co., Ltd.
Chemistry · 27d
Cleared Feb 22, 2019
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
K181551
Runbio Biotech Co.,Ltd
Chemistry · 254d
Cleared Jan 10, 2019
Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
K183097
Weihai Kangzhou Biotechnology Engineering Co., Ltd.
Chemistry · 64d
Cleared May 18, 2018
Acro HCG Pregnancy Rapid Test
K180771
Acro Biotech, Inc.
Chemistry · 56d
Cleared Mar 28, 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627
Runbio Biotech Co.,Ltd
Chemistry · 208d
Cleared Mar 12, 2018
Preview Digital Pregnancy Test
K173229
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 159d
Cleared Feb 02, 2018
ACRO HCG Pregnancy Rapid Test
K172512
Acro Biotech, Inc.
Chemistry · 165d
Cleared Nov 20, 2017
LIA Pregnancy Test
K171136
Lia Diagnostics
Chemistry · 217d
Cleared Apr 07, 2016
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
K142754
Sugentech, Inc.
Chemistry · 560d
Cleared Oct 02, 2015
One Step hCG Pregnancy Test
K150063
Coretests, Inc.
Chemistry · 262d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
K150022
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 213d
Cleared Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085
Co-Innovation Biotech Co., Ltd.
Chemistry · 130d
Cleared Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
K131236
Ucp Biosciences, Inc.
Chemistry · 190d
Cleared Sep 10, 2013
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K123567
Church & Dwight Co., Inc.
Chemistry · 294d
Cleared Aug 26, 2013
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
K123436
Church & Dwight Co., Inc.
Chemistry · 292d
Cleared Jul 26, 2013
CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
K131931
Chemtron Biotech, Inc.
Chemistry · 29d
Cleared Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
K123703
Healgen Scientific, LLC
Chemistry · 128d