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
73–96 of 375
Cleared Jun 11, 1997
ACCUTEST HCG-URINE
K971886
Unotech Diagnostics, Inc.
Chemistry · 20d
Cleared Apr 25, 1997
ACCULINE PREGNANCY TEST
K971122
Genix Biotek, Inc.
Chemistry · 29d
Cleared Apr 04, 1997
CLINITEK HCG TEST STRIPS
K971209
Bayer Corp.
Chemistry · 2d
Cleared Mar 06, 1997
EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
K970424
Excel Scientific, Inc.
Chemistry · 30d
Cleared Feb 20, 1997
ACCUPACK PREGNANCY TEST
K964633
Genix Biotek, Inc.
Chemistry · 93d
Cleared Feb 20, 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116
Abbott Laboratories
Chemistry · 62d
Cleared Feb 18, 1997
SAS SERUM/URINE HCG
K965250
Sascie
Chemistry · 64d
Cleared Feb 18, 1997
SAS PREGNANCY STRIP
K965253
Sascie
Chemistry · 64d
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 Feb 04, 1997
OSOM CLASSIC HCG-URINE TEST (115)
K965227
Wyntek Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 21, 1997
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
K964574
Athena Medical Corp.
Chemistry · 68d
Cleared Jan 21, 1997
SAS ONE-STEP PREGNANCY
K964995
Sa Scientific, Inc.
Chemistry · 36d
Cleared Dec 04, 1996
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
K963231
Excel Scientific, Inc.
Chemistry · 107d
Cleared Nov 25, 1996
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
K964155
Genzyme Diagnostics
Chemistry · 40d
Cleared Nov 25, 1996
CONTRAST STRIP HCG
K964156
Genzyme Diagnostics
Chemistry · 40d
Cleared Nov 18, 1996
MINI STRIP/SERUM HCG
K963132
International Newtech Development, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
PS-UNIT CASSETTE/SERUM HCG
K963133
International Newtech Development, Inc.
Chemistry · 98d
Cleared Oct 18, 1996
VISUALINE D HCG
K963408
Sun Biomedical Laboratories, Inc.
Chemistry · 50d
Cleared Aug 23, 1996
SCRIPPS LABORATORIES HCG ONE-STEP
K962906
Scripps Laboratories, Inc.
Chemistry · 29d
Cleared Jul 10, 1996
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
K954065
Biochem Immunosystems (U.S.), Inc.
Chemistry · 315d
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