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JHI

375 FDA 510(k) clearances · Product code

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RecordFirmDate
MILENIA(TM) HCG (MKCG1,5) (K895809)Diagnostic Products Corp.1989-12-01
IMMUNOCARD HCG II-S TEST KIT (K895912)Disease Detection International, Inc.1989-12-01
CARDS O.S. (TM) HCG-URINE (K895390)Pacific Biotech, Inc.1989-11-13
COAT-A-COUNT (TM) HCG IRMA (K894941)Diagnostic Products Corp.1989-10-25
QUIDEL HCG TEST (K894790)Quidel Corp.1989-10-25
BIOSPOT HCG-RAPID PREGNANCY TEST (K894705)Princeton Biomedix1989-10-18
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (K894750)Princeton Biomedix1989-10-18
ORTHO RESULT PLUS/PREGNANCY (K894420)Ortho Diagnostic Systems, Inc.1989-10-04
IMX TOTAL B-HCG (K894182)Abbott Laboratories1989-09-26
ABBOTT TESTPACK PLUS HCG URINE (K894408)Abbott Laboratories1989-09-05
MINICLINIC PREGNANCY TEST (K894012)Vanguard Biomedical Corp.1989-07-25
HCG IRMA II (K891770)Pacific Biotech, Inc.1989-05-24
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST (K890615)Quidel Corp.1989-04-18
VENTREX COATED TUBE HCG (K890549)Ventrex Laboratories, Inc.1989-03-28
TARGET(TM) QUANTITATIVE HCG (K890131)V-Tech, Inc.1989-03-09
FIRSTDAY EARLY PREGNANCY TESTING KIT II (K884616)Pacific Biotech, Inc.1989-01-13
PREGNAGEN(TM) (K884880)Biogenex Laboratories1989-01-13
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY (K883927)Ciba Corning Diagnostics Corp.1988-10-13
CLEARVIEW HCG (K883777)Unipath , Ltd.1988-10-06
MODIFIED HCG IRMA KIT (K883639)Pacific Biotech, Inc.1988-10-06
PREGNAGEN(TM) (K882002)Biogenex Laboratories1988-09-09
FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT (K881015)Pacific Biotech, Inc.1988-08-29
COTUBE HCG IRMA TEST (K882155)Bio-Rad1988-08-08
QLT ABSOLUTE URINE-HCG PREGNANCY TEST (K881806)Quadra Logic Technologies, Inc.1988-08-02
QTEST(TM) PREGNANCY (K882086)Quidel Corp.1988-07-28
IMMUNOCARD(TM) HCG II TEST KIT (K881709)Disease Detection International, Inc.1988-07-08
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT (K881355)Amersham Corp.1988-06-08
QUIDEL PREGNANCY TEST (K881595)Quidel Corp.1988-05-27
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (K881005)Icn Biomedicals, Inc.1988-05-27
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT (K880410)Disease Detection International, Inc.1988-04-05
ABBOTT IMX HCG (K880070)Abbott Laboratories1988-03-24
CONCEP-7-BHCG (K880577)Leeco Diagnostics, Inc.1988-03-15
KODAK SURECELL(TM) HCG-URINE KIT (K874388)Eastman Kodak Company1988-02-08
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X (K874033)Diagnostic Products Corp.1988-01-05
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 (K873788)Pacific Biotech, Inc.1987-11-23
VENTRESCREEN, HCG URINE (K874258)Ventrex Laboratories, Inc.1987-11-23
RESULT PLUS/HCG PREGNANCY TEST (K872730)Ortho Diagnostic Systems, Inc.1987-10-20
AFFINITY HCG IMMUNIT (POLYCLONAL) (K873524)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-06
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE (K873033)Serono Diagnostics, Inc.1987-09-14
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM (K872390)Nichols Institute Diagnostics1987-09-02
BINAX IRMA TOTAL BETA-HCG TEST KIT (K872728)Binax, Inc.1987-08-05
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES (K872130)Syva Co.1987-07-16
HCG MAB SOLID PHASE COMPONENT SYSTEM (K871700)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-15
ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT (K871308)Allelix, Inc.1987-06-11
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT (K871235)Hybritech, Inc.1987-06-03
AFFINITY (TM) HCG IMMUNIT (TM) (K870627)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST (K870751)Syntron Bioresearch, Inc.1987-05-20
ABBOTT TESTPACK HCG COMBO (K870739)Abbott Laboratories1987-05-20
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY (K870521)Hybritech, Inc.1987-04-08
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD (K870672)E.I. Dupont DE Nemours & Co., Inc.1987-04-01
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE (K864174)United Biotech, Inc.1987-03-13
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS (K870106)Diagnostic Products Corp.1987-03-13
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (K870259)Leeco Diagnostics, Inc.1987-03-10
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY (K865057)Hybritech, Inc.1987-03-10
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST (K865076)Syntron Bioresearch, Inc.1987-02-11
HCG SOLID PHASE COMPONENT SYSTEM (K864591)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-04
VIS-CUBE HCG (EIA) (K863933)Leeco Diagnostics, Inc.1986-12-15
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA (K863861)Hybritech, Inc.1986-11-21
ABBOTT TESTPACK (TM) HCG SERUM (K863032)Abbott Laboratories1986-09-15
CARDS(TM) HCG-URINE (K863199)Pacific Biotech, Inc.1986-09-15
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS (K862247)V-Tech, Inc.1986-07-29
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS (K862262)Serono Diagnostics, Inc.1986-07-29
HCG IRMA, CAT. NO. CR-1501 (K862007)Pacific Biotech, Inc.1986-07-01
BETA QUIK STICK (K860965)Pacific Biotech, Inc.1986-04-24
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY (K860490)Medix Biotech, Inc.1986-03-05
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT (K860542)Hybritech, Inc.1986-03-05
HCG RIA TEST SYSTEM (K854958)Monobind1986-01-28
CANWEST-PREGBLUE (K854989)Canwest Medictex, Inc.1986-01-13
MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO (K854059)Bioclinical Systems, Inc.1986-01-13
RAMP URINE HCG ASSAY (K854611)Monoclonal Antibodies, Inc.1985-12-30
LBK 1244 DELFIA HCG KIT (K852760)Lkb Instruments, Inc.1985-12-05
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY) (K854104)Immunchem Corp.1985-12-05
QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (K853925)Nms Pharmaceuticals, Inc.1985-12-02
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (K854024)Corning Medical & Scientific1985-11-26
BETA-HCG MICROTITER PREGNANCY TEST (K853258)Modern Diagnostics, Inc.1985-10-01
VENTRESCREEN HCG URINE (K853748)Vxr, Inc.1985-10-01
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT (K853539)Abbott Laboratories1985-09-25
HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY (K853006)Modern Diagnostics, Inc.1985-09-04
BETA QUIK STAT (K852327)Pacific Biotech, Inc.1985-08-20
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT (K852675)Amersham Corp.1985-07-22
VISUAL SERUM/URINE HCG COMBO KIT (K852437)American Bioclinical, Inc.1985-07-12
BETA HCG EXTENDED RANGE ACCESSORY KIT (K852183)Abbott Laboratories1985-07-09
ECHOCLONAL HCG IRMA (K852201)Bio-Rad1985-06-28
BHCG-ROCHE EIA (K850727)Hoffmann-La Roche, Inc.1985-06-25
UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST (K851076)United Biotech, Inc.1985-05-10
PREGNA-ZYME (K850992)Armkel, LLC1985-05-01
MEDIX VISUAL URINE HCG (7/7) TEST (K850949)Medix Biotech, Inc.1985-04-12
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM (K850987)Medix Biotech, Inc.1985-04-08
LEECO CONCEP-7-BHCG EIA (K850531)Leeco Diagnostics, Inc.1985-04-02
LEECO CONCEP-7-BHCG IRMA (K850530)Leeco Diagnostics, Inc.1985-04-02
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY (K850570)American Dade1985-04-02
MODEL SERUM HCG ASSAY (K850730)Monoclonal Antibodies, Inc.1985-04-02
LEECO CONCEP-7-BHCG LEIAD II (K850201)Leeco Diagnostics, Inc.1985-03-04
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT (K850159)Hybritech, Inc.1985-03-04
CONCEP-7-BHCG (EIA) (K844153)Leeco Diagnostics, Inc.1984-12-14
QUEST BETA HCG ENZYME IMMUNOASSAY KIT (K844082)Quidel Corp.1984-11-21
BETA QUIK V (K843795)Pacific Biotech, Inc.1984-10-30
ENCORE HCG REAGENT (K843407)Hybritech, Inc.1984-10-04
EPSILON HCG TEST KIT MONOCLONAL (K842654)Beckman Instruments, Inc.1984-10-01
NMS 1043 ENZYME IMMUNOASSAY KIT (K842499)Nms Pharmaceuticals, Inc.1984-09-14
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