Agglutination Method, Human Chorionic Gonadotropin

FDA product code JHJ · 96 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1155
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-09-12 – 1997-08-29

JHJ 1997-08-29

PREGNACOL PREGNANCY TEST

Applicant Immunostics Inc.,

K number K972606

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JHJ 1996-06-28

IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST

Applicant Tech-Co, Inc.

K number K921968

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JHJ 1994-02-24

SAS(TM) DIRECT MONOCLONAL HCG

Applicant Sa Scientific, Inc.

K number K935863

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JHJ 1993-07-28

ACCUTEX BETA-HCG TEST

Applicant J.S. Medical Assoc.

K number K926112

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JHJ 1993-03-29

SAS(TM) MONOCLONAL HCG-SLIDE

Applicant Sa Scientific, Inc.

K number K930609

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JHJ 1992-03-24

DIRECT PREGNANCY TEST

Applicant Tech-Co, Inc.

K number K920716

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JHJ 1991-04-01

CLEARVIEW HCG

Applicant Unipath , Ltd.

K number K910946

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JHJ 1988-05-27

PREGNOSPIA II

Applicant Organon Teknika Corp.

K number K881435

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JHJ 1988-05-17

PREGNANCY (HCG) CARD & LIQUID TEST

Applicant Ampcor, Inc.

K number K880163

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JHJ 1988-04-28

PREGNANCY BETA-HCG CARD & LIQUID TEST

Applicant Ampcor, Inc.

K number K880478

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JHJ 1988-03-15

HCG-NOSTICK

Applicant Organon Teknika Corp.

K number K880328

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JHJ 1988-02-02

V-TREND BETA-HCG DRY-SPOT TEST

Applicant Texas Immunology, Inc.

K number K875262

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JHJ 1988-01-21

V-TREND BETA-HCG TEST

Applicant Texas Immunology, Inc.

K number K874638

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JHJ 1987-05-12

ACU-PREG-AL SLIDE TEST

Applicant Papibris Scientific, Inc.

K number K871294

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JHJ 1986-11-13

IMMUNO-CEPT D (BETA-MONOCLONAL)

Applicant Immunostics Co., Inc.

K number K863741

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JHJ 1986-11-05

MONO ACU-SLIDE TEST

Applicant Cal-Tech Diagnostics, Inc.

K number K861211

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JHJ 1986-09-29

PREGNASLIDE

Applicant Armkel, LLC

K number K863198

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JHJ 1986-07-29

LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)

Applicant Leeco Diagnostics, Inc.

K number K861703

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JHJ 1986-07-11

DELFIA (TM) HCG KIT

Applicant Lkb Instruments, Inc.

K number K862044

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JHJ 1986-07-07

DIRECT ACU-SLIDE TEST

Applicant Cal-Tech Diagnostics, Inc.

K number K861212

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JHJ 1986-07-02

HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY

Applicant Hygeia Sciences

K number K862083

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JHJ 1986-05-02

DIRECTACLONE CG SLIDE PREGNANCY TEST

Applicant Pacific Biotech, Inc.

K number K860945

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JHJ 1986-02-13

TERUMO SENSIBEAD EIG HCG KIT

Applicant Terumo Medical Corp.

K number K854670

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JHJ 1985-09-04

ACU-SLIDE-TEST

Applicant Cal-Tech Diagnostics, Inc.

K number K853247

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JHJ 1985-07-09

DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST

Applicant Sero-Immuno Diagnostics, Inc.

K number K852286

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JHJ 1985-06-25

PREGNANCY CARD TEST

Applicant Em Diagnostic Systems, Inc.

K number K852066

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JHJ 1985-04-08

PRECO PREGNANCY RAPID CARD TEST, HEM #2028

Applicant Preco, Inc.

K number K850604

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JHJ 1985-03-04

FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES

Applicant Fisher Diagnostics

K number K844346

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JHJ 1985-02-12

ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN

Applicant Abbott Laboratories

K number K844914

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JHJ 1985-01-23

FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT

Applicant Fisher Diagnostics

K number K844347

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JHJ 1984-09-21

STANBIO QUICK-TELL MONOCLONAL INDIRECT

Applicant Stanbio Laboratory

K number K842544

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JHJ 1984-08-24

DUOCLON COLOR-CEPT

Applicant Organon, Inc.

K number K842314

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JHJ 1984-08-22

BETA-HCG HEMAGGLUTINATION TEST

Applicant Sero-Immuno Diagnostics, Inc.

K number K842181

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JHJ 1984-07-12

SLIDE PREGNANCY TEST

Applicant Immunostics Co., Inc.

K number K842110

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JHJ 1984-06-22

PREG-BETA ONE HOUR TUBE TEST

Applicant Intl. Diagnostic, Inc.

K number K841853

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JHJ 1984-05-30

PREG BETA BLUS SLIDE

Applicant Intl. Diagnostic, Inc.

K number K840833

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JHJ 1984-04-19

PLUS URINE HCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K840738

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JHJ 1984-04-04

B-NEOCEPT 30

Applicant Organon, Inc.

K number K840650

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JHJ 1984-02-04

BHCG-CHECK

Applicant Diagnostic Technology, Inc.

K number K834346

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JHJ 1984-02-03

FERTITUBE PREGNANCY TEST #1120

Applicant Stanbio Laboratory

K number K832867

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JHJ 1984-01-18

ORTHO B-HCG SLIDE TEST FOR PREGNANCY

Applicant Ortho Diagnostic Systems, Inc.

K number K833137

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JHJ 1984-01-09

PREGNASTICK URINE HCG KIT

Applicant Monoclonal Antibodies, Inc.

K number K833504

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JHJ 1983-11-25

QUIDEL HCG ENZYME IMMUNOASSAY KIT

Applicant Quidel Corp.

K number K833156

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JHJ 1983-11-03

PREGNA-TEC

Applicant Medilab Corp.

K number K832918

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JHJ 1983-10-28

B-SLIDE PREGNATE PREGNANCY TEST KIT

Applicant Fisher Scientific Co., LLC

K number K832879

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JHJ 1983-10-04

QUICK-TELL INDIRECT PREGNANCY TEST

Applicant Stanbio Laboratory

K number K832640

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JHJ 1983-09-20

EARLY IN HOME PREGNANCY TEST

Applicant Warner-Lambert Co.

K number K832599

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JHJ 1983-09-12

FERTITELL DIRECT PREGNANCY TEST #1100

Applicant Stanbio Laboratory

K number K832557

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JHJ 1983-09-12

PREGNA-TEC

Applicant Medilab Corp.

K number K832527

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JHJ 1983-08-16

GAMMA SLIDE TEST FOR PREGNANCY

Applicant Gamma Biologicals, Inc.

K number K832473

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JHJ 1983-08-11

UCG-BETA SLIDE MONOCLONAL

Applicant Armkel, LLC

K number K831775

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JHJ 1983-06-30

E.P.T. PLUS TM

Applicant Warner-Lambert Co.

K number K831535

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JHJ 1983-06-22

B HCG-CHECK

Applicant Diagnostic Technology, Inc.

K number K831468

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JHJ 1983-06-22

HCG-CHECK

Applicant Diagnostic Technology, Inc.

K number K831466

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JHJ 1983-06-22

EVENT-TEST SLIDE

Applicant Icl Scientific

K number K831383

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JHJ 1983-06-08

NEO-PREGNOSTICON DUOCLON TUBE TEST

Applicant Organon, Inc.

K number K831339

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JHJ 1983-06-02

TESTCORP PREG

Applicant Catheter Technology Corp.

K number K831366

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JHJ 1983-06-02

BETA-PREG

Applicant Catheter Technology Corp.

K number K831361

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JHJ 1983-06-02

B-CLONE HCG ASSAY

Applicant Monoclonal Antibodies, Inc.

K number K831155

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JHJ 1983-05-27

PREGNA-CERT, SLIDE PREGNANCY TEST

Applicant Diagnostic Specialties

K number K831180

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JHJ 1983-05-05

BTC URINE LCG ASSAY

Applicant Btc Diagnostics, Inc.

K number K831125

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JHJ 1983-02-09

HCG SCREENING TEST

Applicant Tago, Inc.

K number K830156

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JHJ 1983-01-07

BETA FFIRM TEST

Applicant Organon, Inc.

K number K823682

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JHJ 1982-07-16

PREG-PHILE B

Applicant Bio Diagnostic Systems, Inc.

K number K821676

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JHJ 1982-06-11

PREG-KNOW

Applicant Immuno Pathology Labs

K number K821552

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JHJ 1982-06-02

PREG/TEX PREGNANCY TEST

Applicant Texas Immunology, Inc.

K number K821387

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JHJ 1981-12-17

ACU-SLIDE TEST

Applicant C.F. Medical, Inc.

K number K812789

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JHJ 1981-12-17

A-1 TEST

Applicant C.F. Medical, Inc.

K number K812788

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JHJ 1981-11-06

ACCURATE BETA

Applicant Organon, Inc.

K number K812967

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JHJ 1981-11-02

ANSWER (R)

Applicant Armkel, LLC

K number K812924

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JHJ 1981-09-01

B-NEOCEPT

Applicant Organon, Inc.

K number K812334

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JHJ 1981-08-31

ACCURATE I

Applicant Organon, Inc.

K number K812261

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JHJ 1981-08-03

OREIA II, B-HCG

Applicant Organon, Inc.

K number K811940

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JHJ 1981-07-27

NEOCEPT

Applicant Organon, Inc.

K number K811941

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JHJ 1981-03-17

FACT* HOME PREGNANCY TEST

Applicant Ortho Pharmaceutical Corp.

K number K810581

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JHJ 1980-12-19

RAPI-DOT

Applicant Organon, Inc.

K number K802974

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JHJ 1980-11-24

ANSWER AT-HOME PREGNANCY TEST KIT

Applicant Armkel, LLC

K number K802660

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JHJ 1980-10-31

GESTATE SLIDE EIKEN KIT AGG. METHOD HUM

Applicant Syn-Kit, Inc.

K number K802450

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JHJ 1980-10-23

UCG-BETA SLIDE

Applicant Armkel, LLC

K number K802435

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JHJ 1980-10-23

UCG-BETA STAT

Applicant Armkel, LLC

K number K802421

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JHJ 1980-10-10

PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO

Applicant Intl. Diagnostic, Inc.

K number K802343

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JHJ 1980-10-10

IN-HOME EARLY PREGNANCY TEST KIT

Applicant Health Diagnostics Corp.

K number K802334

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JHJ 1980-01-29

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON

Applicant Technam, Inc.

K number K800055

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JHJ 1980-01-16

SENSI-SLIDE

Applicant Hoffmann-La Roche, Inc.

K number K792657

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JHJ 1979-10-30

PREGTELL I

Applicant Central Biological Co.

K number K792027

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JHJ 1979-10-17

BE-SURE

Applicant Precision Products Corp.

K number K791706

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JHJ 1979-10-02

BE-SURE

Applicant Biologics Intl., Inc.

K number K791609

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JHJ 1979-07-30

UCG-LYPHOTEST

Applicant Wampole Laboratories

K number K791309

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JHJ 1979-07-30

PREG-TEX

Applicant Biologics Intl., Inc.

K number K790898

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JHJ 1979-06-15

PREGNOSTICON PREGNANCY TEST KIT

Applicant Organon, Inc.

K number K790734

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JHJ 1979-04-04

SLIDE TEST FOR PREGNANCY, GRAVINDEX 90

Applicant Ortho Diagnostics, Inc.

K number K782166

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JHJ 1979-04-04

PREGNANCY, SENSIDEX TUBE TEST

Applicant Ortho Diagnostics, Inc.

K number K782063

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JHJ 1979-03-21

SENSI-TEX

Applicant Hoffmann-La Roche, Inc.

K number K790267

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JHJ 1979-02-01

PREGNANCY TEST KIT, DAISY 2 IN HOME

Applicant Boehringer Mannheim Corp.

K number K790002

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JHJ 1978-06-29

ACU-TEST IN-HOME PREGNANCY TEST

Applicant Williams, the J.B. Co., Inc.

K number K781049

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JHJ 1977-09-12

PREGNANCY TEST KIT

Applicant Generic Laboratory, Ltd.

K number K771514

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