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
49–72 of 375
Cleared Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732
Bio-Rad Laboratories, Inc.
Chemistry · 49d
Cleared Oct 16, 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273
Quidel Corp.
Chemistry · 33d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029
Abbott Laboratories
Chemistry · 38d
Cleared Jun 20, 1995
CONTRAST & RAPID HCG URINE/SERUM TST
K952319
Medix Biotech, Inc.
Chemistry · 33d
Cleared Jan 27, 1995
RAPIDVUE(TM) HCG
K945969
Quidel Corp.
Chemistry · 51d
Cleared Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426
Princeton BioMeditech Corp.
Chemistry · 43d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673
Abbott Laboratories
Chemistry · 207d
Cleared Apr 15, 1994
ONE STEP PREGNANCY TEST
K936031
Teco Diagnostics
Chemistry · 119d
Cleared Apr 08, 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138
Eastman Kodak Company
Chemistry · 106d
Cleared Apr 08, 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287
Eastman Kodak Company
Chemistry · 106d
Cleared Sep 28, 1993
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758
Medix Biotech, Inc.
Chemistry · 117d
Cleared Jul 08, 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279
Pb Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Jun 29, 1993
QUICKVUE ONE-STEP HCG COMBO
K932042
Quidel Corp.
Chemistry · 63d
Cleared Jun 09, 1993
SAS PREGNANCY STRIP
K931302
Sa Scientific, Inc.
Chemistry · 86d
Cleared May 11, 1993
CLEARVIEW HCG
K924673
Unipath , Ltd.
Chemistry · 237d
Cleared Mar 19, 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277
Ciba Corning Diagnostics Corp.
Chemistry · 150d
Cleared Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342
Syva Co.
Chemistry · 62d
Cleared Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
K926198
Bio-Rad Laboratories, Inc.
Chemistry · 61d
Cleared Feb 02, 1993
SAS ONE STEP PREGNANCY
K926204
Sa Scientific, Inc.
Chemistry · 55d
Cleared Dec 03, 1992
QUICKVUE ONE-STEP HCG TEST
K925435
Quidel Corp.
Chemistry · 36d
Cleared Nov 25, 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259
Medix Biotech, Inc.
Chemistry · 93d
Cleared Oct 01, 1992
VISUAL HCG PREGNANCY TEST
K923376
Tech-Co, Inc.
Chemistry · 84d
Cleared Aug 10, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 67d
Cleared Jul 28, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302
Vitek Systems, Inc.
Chemistry · 131d