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
145–168 of 226
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 23, 1995
OSOM PREGNANCY TEST
K954178
Wyntek Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 13, 1995
CAMEO HOME PREGNANCY TEST
K954364
Quidel Corp.
Chemistry · 25d
Cleared Jul 19, 1995
HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY
K950354
Ml Strategies, Inc.
Chemistry · 170d
Cleared Feb 10, 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514
Princeton BioMeditech Corp.
Chemistry · 93d
Cleared Jan 27, 1995
ADVANCE(R) PREGNANCY TEST
K945846
Advanced Care Products
Chemistry · 58d
Cleared Jan 17, 1995
HCG MIDSTREAM PREGNANCY TEST
K945568
Mizuho USA, Inc.
Chemistry · 68d
Cleared Oct 20, 1994
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
K941765
Tcpi, Inc.
Chemistry · 209d
Cleared Jul 06, 1994
PREGNANCY CHECK
K941355
Sa Scientific, Inc.
Chemistry · 107d
Cleared Jul 06, 1994
BODYWISE PREGNANCEY TEST
K941771
Charlton Assoc.
Chemistry · 86d
Cleared Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
K940637
Organon Teknika Corp.
Chemistry · 108d
Cleared May 19, 1994
ANI BIOCARD(TM) HCG TEST
K933794
Canadian Bioclinical, Ltd.
Chemistry · 288d
Cleared Feb 25, 1994
EVATEST STRIP
K936013
Boehringer Mannheim Italia Spa
Chemistry · 71d
Cleared Feb 24, 1994
ADVANCE PREGNANCY TEST MODIFICATION
K934516
Ortho Pharmaceutical Corp.
Chemistry · 160d
Cleared Dec 02, 1993
HCG PREGNANCY ONE STEP TEST STRIP
K934830
Tcpi, Inc.
Chemistry · 55d
Cleared Sep 10, 1993
HCG MIDSTREAM PREGNANCY TEST
K931997
Mizuho USA, Inc.
Chemistry · 140d
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 Jan 26, 1993
LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST
K926308
Princeton Biomedix
Chemistry · 42d