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
169–192 of 226
Cleared Jan 06, 1993
PREGNAGEN 1-STEP PREGNANCY TEST
K925189
Biogenex Laboratories
Chemistry · 85d
Cleared Dec 28, 1992
CONCEIVE ONE-STEP PREGNANCY TEST
K925096
Quidel Corp.
Chemistry · 81d
Cleared May 29, 1992
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
K921099
Syntron Bioresearch, Inc.
Chemistry · 81d
Cleared Apr 08, 1992
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
K921012
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 36d
Cleared Dec 23, 1991
ADVANCE(R) PREGNANCY TEST
K914990
Ortho Pharmaceutical Corp.
Chemistry · 46d
Cleared Oct 17, 1991
HOMECLINIC ONE STEP PREGNANCY TEST
K914254
Vanguard Biomedical Corp.
Chemistry · 24d
Cleared Oct 17, 1991
FIRST RESPONSE(R) ONE-STEP
K914304
Armkel, LLC
Chemistry · 22d
Cleared Jul 24, 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316
Syntron Bioresearch, Inc.
Chemistry · 61d
Cleared May 06, 1991
CLEARBLUE EASY
K911566
Unipath , Ltd.
Chemistry · 27d
Cleared Feb 13, 1991
CLEARBLUE EASY
K905742
Unipath , Ltd.
Chemistry · 51d
Cleared Dec 06, 1990
ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
K904782
Carter Products
Chemistry · 45d
Cleared Aug 02, 1990
ABBOTT MODIFIED FACT PLUS PREGNANCY TEST
K901981
Abbott Laboratories
Chemistry · 92d
Cleared Mar 06, 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482
Pacific Biotech, Inc.
Chemistry · 113d
Cleared Nov 13, 1989
MODIFIED HOMECLINIC PREGNANCY TEST
K895560
Vanguard Biomedical Corp.
Chemistry · 68d
Cleared Mar 08, 1989
C&T PREGNANCY TEST KIT
K884489
Healthcheck Corp.
Chemistry · 133d
Cleared Jan 30, 1989
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430
Disease Detection International, Inc.
Chemistry · 168d
Cleared Nov 29, 1988
HOME CLINIC PREGNANCY TEST
K883826
Vanguard Biomedical Corp.
Chemistry · 81d
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 May 16, 1988
ADVANCE* AND DAISY* PREGNANCY TEST
K880472
Advanced Care Products
Chemistry · 102d
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