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
193–216 of 226
Cleared Aug 26, 1987
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
K871601
Advanced Care Products
Chemistry · 124d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996
Abbott Laboratories
Chemistry · 84d
Cleared Jan 14, 1987
CARDS(TM) - EARLY PREGNANCY TEST
K863341
Pacific Biotech, Inc.
Chemistry · 139d
Cleared Jan 09, 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999
Leeco Diagnostics, Inc.
Chemistry · 87d
Cleared Jan 09, 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373
Unipath , Ltd.
Chemistry · 65d
Cleared Dec 22, 1986
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841
Hybritech, Inc.
Chemistry · 82d
Cleared Jun 17, 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207
Quidel Corp.
Chemistry · 7d
Cleared Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946
Healthcheck Corp.
Chemistry · 27d
Cleared Apr 24, 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168
Unipath , Ltd.
Chemistry · 27d
Cleared Apr 21, 1986
MUREX (TM), SUDS (TM), HCG ASSAY
K860451
Murex Corp.
Chemistry · 75d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090
Armkel, LLC
Chemistry · 91d
Cleared Oct 03, 1985
PREGNA/TEST
K853269
Modern Diagnostics, Inc.
Chemistry · 59d
Cleared Jun 28, 1985
ANSWER
K852274
Armkel, LLC
Chemistry · 30d
Cleared Mar 05, 1985
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
K850079
Bioclinical Systems, Inc.
Chemistry · 54d
Cleared Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281
Healthcheck Corp.
Chemistry · 35d
Cleared Sep 28, 1984
H.P.T. HOME PREG. TEST KIT & A.P.T.
K834474
Biomedical Research & Development Laboratories, Inc.
Chemistry · 283d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238
Armkel, LLC
Chemistry · 23d
Cleared Jul 17, 1984
ORTHO BRAND HOME PREGNANCY TEST
K842265
Advanced Care Products
Chemistry · 40d
Cleared Jul 11, 1984
BETA STICK, PREGNANCY TEST
K841415
Quidel Corp.
Chemistry · 97d
Cleared May 31, 1984
HEALTHCHECK HOME PREGNANCY TEST KIT
K841595
Timex Medical Products Corp.
Chemistry · 43d
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602
Organon, Inc.
Chemistry · 34d
Cleared May 14, 1984
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
K834270
Advanced Care Products
Chemistry · 158d
Cleared Mar 19, 1984
VERIFY PREGNANCY TEST KIT
K840602
O.T.C. Diagnostics, Inc.
Chemistry · 38d
Cleared Feb 03, 1984
QUALITATIVE ENZYME IMMUNOASSAY-DETECT
K832905
Btc Diagnostics, Inc.
Chemistry · 158d