ClearanceBrief
Panels › Clinical Chemistry › Product code JHI · Class 2

Visual, Pregnancy Hcg, Prescription Use

Regulation 862.1155

1510(k)s in 12 months (376 all time)
4recalls in 12 months (47 all time)
34recalls that name a 510(k)
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Top companies in JHI

Company510(k)sRecalls
Quidel Corp.201
Abbott Laboratories150
Hybritech, Inc.140
Pacific Biotech, Inc.130
Leeco Diagnostics, Inc.100
Bd Becton Dickinson Vacutainer Systems Preanalytic90
Medix Biotech, Inc.90
Sa Scientific, Inc.90
Mainline Technology, Inc.17
Hoffmann-La Roche, Inc.70
Decided510(k)Device and applicantCode
Apr 1, 1987K870672ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD
E.I. Dupont DE Nemours & Co., Inc.
JHI
Mar 13, 1987K870106COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
Diagnostic Products Corp.
JHI
Mar 13, 1987K864174UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE
United Biotech, Inc.
JHI
Mar 10, 1987K870259VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044
Leeco Diagnostics, Inc.
JHI
Mar 10, 1987K865057TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
Hybritech, Inc.
JHI
Feb 11, 1987K865076SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
Syntron Bioresearch, Inc.
JHI
Feb 4, 1987K864591HCG SOLID PHASE COMPONENT SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
JHI
Dec 15, 1986K863933VIS-CUBE HCG (EIA)
Leeco Diagnostics, Inc.
JHI
Nov 21, 1986K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
Hybritech, Inc.
JHI
Sep 15, 1986K863199CARDS(TM) HCG-URINE
Pacific Biotech, Inc.
JHI
Sep 15, 1986K863032ABBOTT TESTPACK (TM) HCG SERUM
Abbott Laboratories
JHI
Jul 29, 1986K862262HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
Serono Diagnostics, Inc.
JHI
Jul 29, 1986K862247TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
V-Tech, Inc.
JHI
Jul 1, 1986K862007HCG IRMA, CAT. NO. CR-1501
Pacific Biotech, Inc.
JHI
Apr 24, 1986K860965BETA QUIK STICK
Pacific Biotech, Inc.
JHI
Mar 5, 1986K860542TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
Hybritech, Inc.
JHI
Mar 5, 1986K860490MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
Medix Biotech, Inc.
JHI
Jan 28, 1986K854958HCG RIA TEST SYSTEM
Monobind
JHI
Jan 13, 1986K854989CANWEST-PREGBLUE
Canwest Medictex, Inc., CA
JHI
Jan 13, 1986K854059MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
Bioclinical Systems, Inc.
JHI
Dec 30, 1985K854611RAMP URINE HCG ASSAY
Monoclonal Antibodies, Inc.
JHI
Dec 5, 1985K854104IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
Immunchem Corp.
JHI
Dec 5, 1985K852760LBK 1244 DELFIA HCG KIT
Lkb Instruments, Inc.
JHI
Dec 2, 1985K853925QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
Nms Pharmaceuticals, Inc.
JHI
Nov 26, 1985K854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
Corning Medical & Scientific
JHI
Oct 1, 1985K853748VENTRESCREEN HCG URINE
Vxr, Inc.
JHI
Oct 1, 1985K853258BETA-HCG MICROTITER PREGNANCY TEST
Modern Diagnostics, Inc.
JHI
Sep 25, 1985K853539ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
Abbott Laboratories
JHI
Sep 4, 1985K853006HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY
Modern Diagnostics, Inc.
JHI
Aug 20, 1985K852327BETA QUIK STAT
Pacific Biotech, Inc.
JHI
Jul 22, 1985K852675AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
Amersham Corp.
JHI
Jul 12, 1985K852437VISUAL SERUM/URINE HCG COMBO KIT
American Bioclinical, Inc.
JHI
Jul 9, 1985K852183BETA HCG EXTENDED RANGE ACCESSORY KIT
Abbott Laboratories
JHI
Jun 28, 1985K852201ECHOCLONAL HCG IRMA
Bio-Rad
JHI
Jun 25, 1985K850727BHCG-ROCHE EIA
Hoffmann-La Roche, Inc.
JHI
May 10, 1985K851076UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST
United Biotech, Inc.
JHI
May 1, 1985K850992PREGNA-ZYME
Armkel, LLC
JHI
Apr 12, 1985K850949MEDIX VISUAL URINE HCG (7/7) TEST
Medix Biotech, Inc.
JHI
Apr 8, 1985K850987MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
Medix Biotech, Inc.
JHI
Apr 2, 1985K850730MODEL SERUM HCG ASSAY
Monoclonal Antibodies, Inc.
JHI
Apr 2, 1985K850570STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
JHI
Apr 2, 1985K850531LEECO CONCEP-7-BHCG EIA
Leeco Diagnostics, Inc.
JHI
Apr 2, 1985K850530LEECO CONCEP-7-BHCG IRMA
Leeco Diagnostics, Inc.
JHI
Mar 4, 1985K850201LEECO CONCEP-7-BHCG LEIAD II
Leeco Diagnostics, Inc.
JHI
Mar 4, 1985K850159TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
Hybritech, Inc.
JHI
Dec 14, 1984K844153CONCEP-7-BHCG (EIA)
Leeco Diagnostics, Inc.
JHI
Nov 21, 1984K844082QUEST BETA HCG ENZYME IMMUNOASSAY KIT
Quidel Corp.
JHI
Oct 30, 1984K843795BETA QUIK V
Pacific Biotech, Inc.
JHI
Oct 4, 1984K843407ENCORE HCG REAGENT
Hybritech, Inc.
JHI
Oct 1, 1984K842654EPSILON HCG TEST KIT MONOCLONAL
Beckman Instruments, Inc.
JHI

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