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 Jun 08, 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404
Unipath , Ltd.
Chemistry · 13d
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
Cleared Jan 16, 2004
E.P.T. PREGNANCY TEST
K033658
Unipath , Ltd.
Chemistry · 56d
Cleared Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041
ACON Laboratories, Inc.
Chemistry · 53d
Cleared Oct 20, 2003
EPT CERTAINTY PREGNANCY TEST
K032939
Unipath , Ltd.
Chemistry · 28d
Cleared Oct 14, 2003
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)
K032661
ACON Laboratories, Inc.
Chemistry · 47d
Cleared Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510
ACON Laboratories, Inc.
Chemistry · 39d
Cleared May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659
Unipath , Ltd.
Chemistry · 60d
Cleared Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
K030258
Armkel, LLC
Chemistry · 32d
Cleared Nov 27, 2002
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699
Unipath , Ltd.
Chemistry · 23d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372
Unipath , Ltd.
Chemistry · 29d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215
ACON Laboratories, Inc.
Chemistry · 22d
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 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 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 Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722
Quidel Corp.
Chemistry · 19d
Cleared Mar 11, 1998
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012
K980532
Phamatech
Chemistry · 28d