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
25–48 of 376
Cleared Aug 11, 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728
Immunostics Inc.,
Chemistry · 47d
Cleared Mar 18, 2004
ZAP HCG TEST, MODEL 8001
K033297
Zbx Corporation
Chemistry · 156d
Cleared Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
K032563
Bayer Healthcare, LLC
Chemistry · 125d
Cleared Nov 17, 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987
Unotech Diagnostics, Inc.
Chemistry · 54d
Cleared Jul 01, 2003
MAINLINE MAXIE HCG URINE PREGNANCY TEST
K031445
Mainline Technology, Inc.
Chemistry · 55d
Cleared Jun 16, 2003
CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
K031048
Access Bio Incorporate
Chemistry · 75d
Cleared May 22, 2003
EASYCUP
K023823
Zer Hitech
Chemistry · 188d
Cleared Apr 18, 2003
POLY STAT SERUM/URINE HCG TEST
K030430
Alidex, Inc.
Chemistry · 67d
Cleared Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944
Bayer Corp.
Chemistry · 77d
Cleared Jan 16, 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544
Genzyme Corp.
Chemistry · 86d
Cleared Dec 20, 2002
ACCESS TOTAL BHCG
K023480
Beckman Coulter, Inc.
Chemistry · 64d
Cleared Dec 16, 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683
Sa Scientific, Inc.
Chemistry · 126d
Cleared Aug 05, 2002
POLY STAT HCG DIPSTICK TEST
K021386
Alidex, Inc.
Chemistry · 95d
Cleared Jul 15, 2002
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
K020968
Pan Probe Biotech, Inc.
Chemistry · 111d
Cleared Jun 21, 2002
QUPID PLUS E.R.
K020378
Stanbio Laboratory
Chemistry · 136d
Cleared May 23, 2002
STATUS HCG SERUM/URINE
K020439
Princeton BioMeditech Corp.
Chemistry · 101d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
K020799
Quidel Corp.
Chemistry · 66d
Cleared May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801
Quidel Corp.
Chemistry · 66d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438
Sa Scientific, Inc.
Chemistry · 25d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Dec 27, 2001
VICTORCH HCG TEST STRIP
K013702
Victorch Meditek, Inc.
Chemistry · 49d
Cleared Oct 16, 2001
POLY STAT HCG TEST
K012559
Bion Diagnostic Sciences
Chemistry · 69d
Cleared Oct 10, 2001
UNIMARK HCG COMBO PREGNANCY TEST
K013194
Biotech Atlantic, Inc.
Chemistry · 15d
Cleared Aug 28, 2001
WH ACCU TEST PREGNANCY TEST
K012284
W.H.P.M., Inc.
Chemistry · 39d