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
97–120 of 226
Cleared Jan 03, 2003
CASSETTE/URINE HCG
K023638
Ind Diagnostic, Inc.
Chemistry · 65d
Cleared Dec 16, 2002
PREG-Q EARLY PREGNANCY TEST
K023027
Yd Diagnostics
Chemistry · 96d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 18, 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126
Ameditech, Inc.
Chemistry · 60d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372
Unipath , Ltd.
Chemistry · 29d
Cleared Aug 14, 2001
SURE CHECK PREGNANCY TEST
K011551
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215
ACON Laboratories, Inc.
Chemistry · 22d
Cleared Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049
Selfcare, Inc.
Chemistry · 24d
Cleared Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483
ACON Laboratories, Inc.
Chemistry · 98d
Cleared Dec 21, 1999
FIRST RESPONSE 1-STEP PREGNANCY
K992232
Armkel, LLC
Chemistry · 172d
Cleared Dec 16, 1999
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333
Unipath , Ltd.
Chemistry · 73d
Cleared Nov 08, 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141
Phamatech
Chemistry · 48d
Cleared May 10, 1999
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
K991369
Germaine Laboratories, Inc.
Chemistry · 20d
Cleared May 04, 1999
SAS HCG-CHECK
K991193
Sa Scientific, Inc.
Chemistry · 26d
Cleared Apr 07, 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262
Unipath , Ltd.
Chemistry · 70d
Cleared Mar 09, 1999
OSOM CARD PREGNANCY TEST, MODEL 103
K990576
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 22, 1999
FACT PLUS ONE STEP PREGNANCY TEST
K990373
Abbott Laboratories
Chemistry · 14d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST
K984075
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Nov 18, 1998
ACON MIDSTREAM PREGNANCY TEST
K983090
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Aug 18, 1998
QUICK & SURE ONESTEP HOME PREGNANCY TEST
K981892
Abacus Diagnostics
Chemistry · 81d
Cleared Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722
Quidel Corp.
Chemistry · 19d
Cleared Apr 09, 1998
ONE STEP MIDSTREAM HCG PREGNANCY TEST
K974059
International Newtech Development, Inc.
Chemistry · 164d
Cleared Mar 11, 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532
Phamatech
Chemistry · 28d