LCX · Class II · 21 CFR 862.1155

FDA Product Code LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Leading manufacturers include Unipath , Ltd., Armkel, LLC and ACON Laboratories, Inc..

226
Total
226
Cleared
104d
Avg days
1978
Since
226 devices
97–120 of 226
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996
Abbott Laboratories
Chemistry · 84d
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 Apr 24, 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168
Unipath , Ltd.
Chemistry · 27d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090
Armkel, LLC
Chemistry · 91d
Cleared Jun 28, 1985
ANSWER
K852274
Armkel, LLC
Chemistry · 30d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238
Armkel, LLC
Chemistry · 23d
Cleared Jul 11, 1984
BETA STICK, PREGNANCY TEST
K841415
Quidel Corp.
Chemistry · 97d
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602
Organon, Inc.
Chemistry · 34d
Cleared Nov 25, 1983
EARLY PREGNANCY DETECTION TEST KIT
K833466
Quidel Corp.
Chemistry · 50d
Cleared May 18, 1983
HOME PREGNANCY TEST KIT HPK #1
K831051
Quidel Corp.
Chemistry · 47d
Cleared May 18, 1983
HOME PREGNANCY TEST KIT
K831108
Quidel Corp.
Chemistry · 43d
Cleared Feb 27, 1978
PREDICTOR
K780240
Organon, Inc.
Chemistry · 14d