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 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 08, 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716
Church & Dwight Co., Inc.
Chemistry · 175d
Cleared May 04, 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K070054
Church & Dwight Co., Inc.
Chemistry · 120d
Cleared Jul 03, 2006
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769
Unipath , Ltd.
Chemistry · 10d
Cleared May 25, 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128
Unipath , Ltd.
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
Cleared May 12, 2005
E.P.T. CERTAINTY PREGNANCY TEST
K050930
Unipath , Ltd.
Chemistry · 28d
Cleared Apr 25, 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231
Mizuho USA, Inc.
Chemistry · 154d
Cleared Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 115d
Cleared Oct 19, 2004
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866
Armkel, LLC
Chemistry · 200d
Cleared Sep 10, 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280
Unipath , Ltd.
Chemistry · 18d
Cleared Sep 09, 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151
ACON Laboratories, Inc.
Chemistry · 31d
Cleared Aug 09, 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
K041748
Azog, Inc.
Chemistry · 41d
Cleared Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404
Unipath , Ltd.
Chemistry · 13d
Cleared May 20, 2004
ONE-STEP PREGNANCY TEST
K041273
W.H.P.M., Inc.
Chemistry · 8d
Cleared Mar 08, 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329
Unipath , Ltd.
Chemistry · 26d
Cleared Mar 08, 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341
Unipath , Ltd.
Chemistry · 25d