LCX · Class II · 21 CFR 862.1155

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

Leading manufacturers include Spd Swiss Precision Diagnostics GmbH, Abbott Laboratories and Guangzhou Decheng Biotechnology Co., Ltd..

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 Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373
Abbott Laboratories
Chemistry · 14d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082
Abbott Laboratories
Chemistry · 15d
Cleared Mar 18, 1993
PRECISE PREGNANCY
K930640
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 49d
Cleared Apr 08, 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 36d
Cleared Aug 02, 1990
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981
Abbott Laboratories
Chemistry · 92d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996
Abbott Laboratories
Chemistry · 84d