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..

375
Total
375
Cleared
70d
Avg days
1976
Since
375 devices
25–48 of 375
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 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
Cleared Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
K981443
Princeton BioMeditech Corp.
Chemistry · 64d
Cleared Apr 02, 1998
QUICKCARD PRO HCG TEST, MODEL 9008
K980896
Phamatech
Chemistry · 24d
Cleared Mar 18, 1998
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173
Beckman Instruments, Inc.
Chemistry · 57d
Cleared Jan 26, 1998
QUICKSTICK PRO HCG TEST
K974615
Phamatech
Chemistry · 46d
Cleared Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052
Quidel Corp.
Chemistry · 53d
Cleared Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841
Quidel Corp.
Chemistry · 54d
Cleared Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
K973858
Quidel Corp.
Chemistry · 48d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748
Quidel Corp.
Chemistry · 37d
Cleared Apr 04, 1997
CLINITEK HCG TEST STRIPS
K971209
Bayer Corp.
Chemistry · 2d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116
Abbott Laboratories
Chemistry · 62d
Cleared Feb 11, 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
K964461
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536
Teco Diagnostics
Chemistry · 91d
Cleared Jan 21, 1997
SAS ONE-STEP PREGNANCY
K964995
Sa Scientific, Inc.
Chemistry · 36d
Cleared Jun 28, 1996
DSL ACTIVE I-HCG ELISA
K961911
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared May 07, 1996
DSL ACTIVE I-HCG IRMA
K960357
Diagnostic Systems Laboratories, Inc.
Chemistry · 103d