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
145–168 of 375
Cleared Jun 26, 1990
OPUS (TM) HCG
K901935
Pb Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Apr 18, 1990
IMX HCG (LIST #03A63)
K900327
Abbott Laboratories
Chemistry · 85d
Cleared Mar 29, 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 23d
Cleared Feb 16, 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587
Medix Biotech, Inc.
Chemistry · 87d
Cleared Feb 08, 1990
ENZYMUN TEST R HCG
K896901
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175
Serono-Baker Diagnostics, Inc.
Chemistry · 187d
Cleared Dec 01, 1989
MILENIA(TM) HCG (MKCG1,5)
K895809
Diagnostic Products Corp.
Chemistry · 90d
Cleared Dec 01, 1989
IMMUNOCARD HCG II-S TEST KIT
K895912
Disease Detection International, Inc.
Chemistry · 52d
Cleared Nov 13, 1989
CARDS O.S. (TM) HCG-URINE
K895390
Pacific Biotech, Inc.
Chemistry · 75d
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790
Quidel Corp.
Chemistry · 89d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941
Diagnostic Products Corp.
Chemistry · 83d
Cleared Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
K894420
Ortho Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182
Abbott Laboratories
Chemistry · 102d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408
Abbott Laboratories
Chemistry · 50d
Cleared May 24, 1989
HCG IRMA II
K891770
Pacific Biotech, Inc.
Chemistry · 61d
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615
Quidel Corp.
Chemistry · 70d
Cleared Mar 28, 1989
VENTREX COATED TUBE HCG
K890549
Ventrex Laboratories, Inc.
Chemistry · 53d
Cleared Mar 09, 1989
TARGET(TM) QUANTITATIVE HCG
K890131
V-Tech, Inc.
Chemistry · 56d
Cleared Jan 13, 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
K884616
Pacific Biotech, Inc.
Chemistry · 70d
Cleared Oct 13, 1988
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Oct 06, 1988
MODIFIED HCG IRMA KIT
K883639
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777
Unipath , Ltd.
Chemistry · 30d
Cleared Aug 29, 1988
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
K881015
Pacific Biotech, Inc.
Chemistry · 172d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155
Bio-Rad
Chemistry · 80d