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
121–144 of 226
Cleared May 01, 1996
MINISTICK PREGNANCY TEST
K960733
Vanguard Biomedical Corp.
Chemistry · 69d
Cleared Apr 29, 1996
CLEARBLUE EASY
K960316
Unipath , Ltd.
Chemistry · 97d
Cleared Apr 01, 1996
UNIMARK MIDSTREAM PREGNANCY TEST STICK
K960174
Biotech Atlantic, Inc.
Chemistry · 76d
Cleared Mar 22, 1996
BEST PREGNANCY TEST
K953606
Ameritek, Inc.
Chemistry · 233d
Cleared Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
K960117
Syntron Bioresearch, Inc.
Chemistry · 68d
Cleared Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
K960436
Selfcare, Inc.
Chemistry · 48d
Cleared Mar 06, 1996
SELFCARE EARLY PREGNANCY TEST
K955903
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 68d
Cleared Oct 13, 1995
CAMEO HOME PREGNANCY TEST
K954364
Quidel Corp.
Chemistry · 25d
Cleared Feb 10, 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514
Princeton BioMeditech Corp.
Chemistry · 93d
Cleared Jul 06, 1994
PREGNANCY CHECK
K941355
Sa Scientific, Inc.
Chemistry · 107d
Cleared Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
K940637
Organon Teknika Corp.
Chemistry · 108d
Cleared Apr 06, 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
K930488
Syntron Bioresearch, Inc.
Chemistry · 67d
Cleared Mar 18, 1993
PRECISE PREGNANCY
K930640
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 49d
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 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 Jan 30, 1989
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430
Disease Detection International, Inc.
Chemistry · 168d