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
145–168 of 226
Cleared Oct 25, 1988
DISCOVER(R)
K882232
Carter Products
Chemistry · 151d
Cleared Oct 06, 1988
BLUE DOT(TM) TEST FOR PREGNANCY
K882588
V-Tech, Inc.
Chemistry · 105d
Cleared Jul 28, 1988
CLEARBLUE EASY
K882416
Unipath , Ltd.
Chemistry · 45d
Cleared Apr 05, 1988
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K874823
Tambrands, Inc.
Chemistry · 133d
Cleared Feb 11, 1988
LEECO PREGNASTICK (EIA) CATALOG #003
K880069
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Nov 04, 1987
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
K874248
Syntron Bioresearch, Inc.
Chemistry · 19d
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 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