JHI · Class II · 21 CFR 862.1155

FDA Product Code JHI: Visual, Pregnancy Hcg, Prescription Use

Leading manufacturers include Quidel Corp., Abbott Laboratories and Hybritech, Inc..

376
Total
376
Cleared
70d
Avg days
1976
Since
376 devices
49–72 of 376
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Jul 31, 2001
SUREVUE URINE HCG
K010522
Sa Scientific, Inc.
Toxicology · 159d
Cleared Apr 05, 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593
Sa Scientific, Inc.
Chemistry · 36d
Cleared Feb 21, 2001
EZ-HCG URINE(PREGNANCY TEST)
K003856
Biomerica, Inc.
Chemistry · 70d
Cleared Jun 22, 2000
DBEST HCG 2 IU/ML TEST KIT
K001215
Ameritek, Inc.
Chemistry · 69d
Cleared Feb 03, 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227
Advantage Diagnostics Corp.
Chemistry · 50d
Cleared Dec 02, 1999
CLEARVIEW EASY HCG PREGNANCY TEST
K993703
Unipath , Ltd.
Chemistry · 30d
Cleared Dec 01, 1999
ACON ONE STEP PREGNANCY TEST STRIP (URINE)
K993203
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Dec 01, 1999
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317
ACON Laboratories, Inc.
Chemistry · 58d
Cleared Nov 18, 1999
ONE-STEP DOUBLE-CHEK PREGNANCY TEST
K992915
Biomedical Products Corp.
Chemistry · 80d
Cleared Oct 18, 1999
INSURE PRO TEST
K992695
Inbios Intl., Inc.
Chemistry · 68d
Cleared Oct 08, 1999
ACON COMBO PREGNANCY
K993065
ACON Laboratories, Inc.
Chemistry · 25d
Cleared Aug 26, 1999
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
K992397
Cenogenics Corp.
Chemistry · 38d
Cleared Jul 22, 1999
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741
Biocheck, Inc.
Chemistry · 62d
Cleared May 10, 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684
Sa Scientific, Inc.
Chemistry · 68d
Cleared May 10, 1999
SAS ONE-STEP PREGNANCY
K990741
Sa Scientific, Inc.
Chemistry · 63d
Cleared Apr 28, 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095
Phamatech
Chemistry · 27d
Cleared Apr 27, 1999
MODIFICATION OF: DAVIDSTRIP HCG
K991067
Simex Medical, Inc.
Chemistry · 28d
Cleared Mar 09, 1999
OSOM CARD II HCG-URINE TEST, MODEL 102
K990578
Wyntek Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
K984079
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Feb 16, 1999
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
K984080
Alfa Scientific Designs, Inc.
Chemistry · 92d
Cleared Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
K981444
Princeton BioMeditech Corp.
Chemistry · 91d