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
49–72 of 226
Cleared Mar 14, 2013
FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
K122907
Polymed Therapeutics, Inc.
Chemistry · 174d
Cleared Feb 05, 2013
EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
K123050
Nantong Biotechnology Co., Ltd.
Chemistry · 130d
Cleared Sep 24, 2012
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
K112449
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 396d
Cleared Oct 04, 2011
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487
Taidoc Technology Corporation
Chemistry · 312d
Cleared Aug 03, 2011
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
K102760
Atlas Medical
Chemistry · 314d
Cleared Jul 28, 2011
PREGNANCY ONE STEP RAPID TEST
K103574
Lehnus & Associates Consulting
Chemistry · 234d
Cleared Jun 20, 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889
Ind Diagnostics, Inc.
Chemistry · 82d
Cleared May 12, 2011
CLEARBLUE EASY PREGNANCY TEST
K110433
SPD Development Company Limited
Chemistry · 86d
Cleared Jun 16, 2009
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150
Turklab Medical Devices, Inc.
Chemistry · 419d
Cleared Jun 08, 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716
Church & Dwight Co., Inc.
Chemistry · 175d
Cleared Dec 18, 2007
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
K071930
Blue Cross Bio-Medical Co., Ltd.
Chemistry · 158d
Cleared Jul 23, 2007
ONE STEP HCG PREGNANCY TEST
K062703
Ai DE Diagnostic Co., Ltd.
Chemistry · 315d
Cleared May 07, 2007
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
K062096
Koreamedico Co. , Ltd.
Chemistry · 287d
Cleared May 04, 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K070054
Church & Dwight Co., Inc.
Chemistry · 120d
Cleared Jul 18, 2006
DAVID PREGNANCY TEST (MIDSTREAM)
K053236
Runbio Biotech Co.,Ltd
Chemistry · 242d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769
Unipath , Ltd.
Chemistry · 10d
Cleared Jun 19, 2006
MULTI-USE ELECTRONIC PREGNANCY TEST
K060825
Mizuho USA, Inc.
Chemistry · 84d
Cleared May 25, 2006
PURE-AID PREGNANCY TEST
K053452
Bio Focus Co., Lt.
Chemistry · 164d
Cleared May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128
Unipath , Ltd.
Chemistry · 127d
Cleared Mar 01, 2006
MYSET PREGNANCY TEST
K053138
Ani Biotech OY
Chemistry · 112d
Cleared Feb 17, 2006
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
K060019
Artron Laboratories, Inc.
Chemistry · 44d
Cleared Nov 23, 2005
BE-CERTAIN PREGNANCY TEST
K051963
Natureplex, LLC
Chemistry · 127d
Cleared May 23, 2005
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
K050305
Bioscreen Medical, Inc.
Chemistry · 104d
Cleared May 20, 2005
ACON +/- MIDSTREAM PREGNANCY TEST
K050546
ACON Laboratories, Inc.
Chemistry · 79d