Radioimmunoassay, Luteinizing Hormone

FDA product code CEP · 143 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1485
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-05-26 – 2003-01-16

CEP 2003-01-16

MAYBE?MOM MINI OVULATION MICROSCOPE

Applicant Maybe?Mom

K number K013582

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CEP 2002-11-05

INSTANT-VIEW LH OVULATION PREDICTING TEST

Applicant Alfa Scientific Designs, Inc.

K number K022829

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CEP 2002-05-24

AT HOME OVULATION TEST, MODEL 9032

Applicant Phamatech, Inc.

K number K021409

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CEP 2002-02-19

CLEARPLANE EASY OVULATION TEST

Applicant Unipath , Ltd.

K number K013874

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CEP 2001-12-05

TCI-31 LIFELONG OVULATION TESTER

Applicant Tci New York

K number K013323

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CEP 2001-08-24

QUIK-CHECK OVULATION PREDICTOR

Applicant ACON Laboratories, Inc.

K number K012252

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CEP 2001-05-02

SURE CHECK OVULATION PREDICTOR

Applicant Chembio Diagnostic Systems, Inc.

K number K010244

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CEP 2000-10-12

INVERNESS MEDICAL OVULATION PREDICTOR TEST

Applicant Selfcare, Inc.

K number K002867

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CEP 1999-05-25

EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)

Applicant Selfcare, Inc.

K number K991466

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CEP 1999-05-25

EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)

Applicant Selfcare, Inc.

K number K991386

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CEP 1999-03-22

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031

Applicant Phamatech

K number K990249

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CEP 1998-11-18

BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

Applicant Syntron Bioresearch, Inc.

K number K983113

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CEP 1998-06-25

CLEARPLAN EASY OVULATION TEST

Applicant Unipath , Ltd.

K number K981271

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CEP 1998-02-02

DBEST ONE-STEP OVULATION TEST

Applicant Ameritek, Inc.

K number K974508

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CEP 1997-10-27

TBD* ONE-STEP OVULATION PREDICTOR TEST

Applicant Armkel, LLC

K number K973310

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CEP 1997-03-18

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT

Applicant Excel Scientific, Inc.

K number K970467

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CEP 1997-02-20

VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K964982

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CEP 1997-01-24

ELECSYS LH ASSAY

Applicant Boehringer Mannheim Corp.

K number K964694

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CEP 1997-01-22

SEALITE SCIENCES, INC. AQUALITE LH

Applicant Sealite Sciences, Inc.

K number K964925

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CEP 1996-11-29

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST

Applicant Princeton BioMeditech Corp.

K number K963693

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CEP 1996-08-23

OPUS HLH

Applicant Behring Diagnostics, Inc.

K number K962866

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CEP 1996-06-21

ACS LH2 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K962041

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CEP 1996-04-23

MINICLINIC OVULATION PREDICTOR

Applicant Vanguard Biomedical Corp.

K number K960233

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CEP 1996-04-05

ACTIVE LH IRMA

Applicant Diagnostic Systems Laboratories, Inc.

K number K961109

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CEP 1995-10-03

FIRST RESPONSE OVULATION PREDICTOR TEST

Applicant Armkel, LLC

K number K953581

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CEP 1995-08-23

CONCEIVE OVULATION PREDICTOR

Applicant Quidel Corp.

K number K953063

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CEP 1995-07-11

BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT

Applicant Syntron Bioresearch, Inc.

K number K951538

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CEP 1995-05-15

COAT-A-COUNT LH IRMA

Applicant Diagnostic Products Corp.

K number K951748

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CEP 1995-04-05

CHEMILUMINESCENCE LH

Applicant Nichols Institute Diagnostics

K number K935319

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CEP 1994-10-25

PRO-STEP LH OVULATION PREDICTION TEST

Applicant Disease Detection International, Inc.

K number K943252

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CEP 1994-10-20

DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD

Applicant Dupont Medical Products

K number K943996

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CEP 1994-10-20

SEALITE SCIENCE, INC. AQUALITE(R) LH

Applicant Sealite Sciences, Inc.

K number K943188

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CEP 1994-09-07

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K942638

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CEP 1994-04-06

ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K940549

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CEP 1994-01-11

ONE STEP LH TEST

Applicant Tcpi, Inc.

K number K935134

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CEP 1993-05-26

COBAS CORE LH EIA

Applicant Roche Diagnostic Systems, Inc.

K number K930306

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CEP 1993-05-26

VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY

Applicant Syva Co.

K number K926394

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CEP 1993-03-04

OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP

Applicant Princeton Biomedix

K number K930185

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CEP 1993-02-02

IMMUCHEM LH-MW ELISA

Applicant Icn Biomedicals, Inc.

K number K922944

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CEP 1992-04-08

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Applicant Vitek Systems, Inc.

K number K921176

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CEP 1992-04-08

ELISA TUBE LH TEST KIT

Applicant Bio Clinic Co.

K number K920920

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CEP 1992-03-11

IMMULITE HLH

Applicant Cirrus Diagnostics, Inc.

K number K920411

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CEP 1992-03-11

LH GEN III SELF-TEST/CONCEIVE

Applicant Quidel Corp.

K number K920160

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CEP 1992-03-02

MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K920504

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CEP 1991-11-07

OPUS(R) LH TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K913938

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CEP 1991-04-12

LH IRMA IMMUNOMAG

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K911050

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CEP 1991-03-21

MINICLINIC OVULATION PREDICTION TEST

Applicant Vanguard Biomedical Corp.

K number K910351

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CEP 1991-03-19

PANTEX IRMA LH 1251 KIT

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K910717

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CEP 1991-02-04

CIBA CORNING ACS LH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K910198

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CEP 1990-11-06

BIOCLONES ELEGANCE LH ELISA KIT

Applicant Bioclone Australia Pty , Ltd.

K number K904387

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CEP 1990-10-12

MILENIA (TM) LH

Applicant Diagnostic Products Corp.

K number K902786

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CEP 1990-08-29

IMMUNOCORP LH IRMA COATED TUBE

Applicant Immunocorp Sciences, Inc.

K number K903052

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CEP 1990-08-02

LUMATAG(TM) LH DIAGNOSTIC KIT

Applicant London Diagnostics, Inc.

K number K902443

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CEP 1990-07-17

MODIFIED OVUGEN

Applicant Biogenex Laboratories

K number K902208

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CEP 1990-06-28

CIBA CORNING MAGIC LITE LH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K902398

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CEP 1990-04-03

ENZYMUN TEST(R) LH

Applicant Boehringer Mannheim Corp.

K number K900779

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CEP 1990-03-01

FIAGEN(TM) HLH.S

Applicant Cyberfluor, Inc.

K number K900621

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CEP 1990-02-13

LUTEINIZING HORMONE-EIA-XT

Applicant In Vitro Diagnostics, Inc.

K number K896866

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CEP 1990-01-30

MODIFIED LH ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K896642

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CEP 1989-10-31

TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT

Applicant Hybritech, Inc.

K number K895094

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CEP 1989-10-12

CLEARPLAN EASY

Applicant Unipath , Ltd.

K number K894579

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CEP 1989-08-15

LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K894279

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CEP 1989-07-20

MINICLINIC OVULATION PREDICTION TEST

Applicant Vanguard Biomedical Corp.

K number K891762

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CEP 1989-06-20

SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K893605

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CEP 1989-03-24

ABBOTT OVULATION PREDICTOR TEST

Applicant Abbott Laboratories

K number K890510

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CEP 1989-03-08

DELFIA HLH SPEC KIT

Applicant Pharmacia, Inc.

K number K883814

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CEP 1988-12-22

COTUBE LH IRMA ASSAY

Applicant Bio-Rad

K number K884498

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CEP 1988-12-19

FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST

Applicant Tambrands, Inc.

K number K883530

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CEP 1988-11-29

ABBOTT IMX LH

Applicant Abbott Laboratories

K number K884138

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CEP 1988-08-08

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA

Applicant Serono Diagnostics, Inc.

K number K882340

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CEP 1988-08-04

PHASE II LH KIT

Applicant Vitek Systems, Inc.

K number K882252

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CEP 1988-07-28

AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST

Applicant Amersham Corp.

K number K880933

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CEP 1988-04-18

ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY

Applicant Nichols Institute Diagnostics

K number K881124

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CEP 1988-04-18

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

Applicant Boots-Celltech Diagnostics, Inc.

K number K880758

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CEP 1988-01-11

FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301

Applicant Cyberfluor, Inc.

K number K874624

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CEP 1987-12-30

IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5

Applicant Diagnostic Products Corp.

K number K874032

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CEP 1987-11-25

O.P.T.(TM) OVULATION PREDICTION TEST

Applicant Warner-Lambert Co.

K number K870584

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CEP 1987-11-23

OVUGEN SURETEST

Applicant Biogenex Laboratories

K number K873534

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CEP 1987-10-07

MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K873668

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CEP 1987-10-02

ANSWER OVULATION TEST KIT

Applicant Armkel, LLC

K number K871241

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CEP 1987-09-29

LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA

Applicant Serono Diagnostics, Inc.

K number K873186

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CEP 1987-09-14

STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K873052

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CEP 1987-08-25

TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY

Applicant Hybritech, Inc.

K number K872131

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CEP 1987-08-05

LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE

Applicant Serono Diagnostics, Inc.

K number K872727

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CEP 1987-08-05

CLEARPLAN

Applicant Unipath , Ltd.

K number K871332

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CEP 1987-07-27

OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)

Applicant Monoclonal Antibodies, Inc.

K number K871726

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CEP 1987-06-11

MICROCHECK LH OVULATION TEST

Applicant Syntron Bioresearch, Inc.

K number K871602

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CEP 1987-02-06

DPC COAT-A-COUNT IRMA LH KIT

Applicant Diagnostic Products Corp.

K number K863934

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CEP 1987-02-04

UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE

Applicant United Biotech, Inc.

K number K863442

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CEP 1987-01-06

CANWEST OVU-BLUE

Applicant Canwest Medictex, Inc.

K number K862055

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CEP 1986-11-24

LUTEINIZING HORMONE (LH-IRMA) RIA KIT

Applicant Immuchem Corp.

K number K864144

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CEP 1986-11-13

TERUMO SENSIBEAD(TM) EIA HLH KIT

Applicant Terumo Medical Corp.

K number K863929

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CEP 1986-10-16

ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM

Applicant Nichols Institute Diagnostics

K number K863679

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CEP 1986-09-16

RIGHT-DAY OVULATION HOME TEST

Applicant Leeco Diagnostics, Inc.

K number K861354

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CEP 1986-08-04

FORETEL, COLOR OVULATION TEST

Applicant Nms Pharmaceuticals, Inc.

K number K860828

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CEP 1986-07-29

RIGHT-DAY URINARY LH (EIA)

Applicant Leeco Diagnostics, Inc.

K number K860538

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CEP 1986-07-07

MODIFIED COTROPIN RADIOIMMUNOASSAY KIT

Applicant Clinetics Corp.

K number K862180

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CEP 1986-04-29

TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT

Applicant Hybritech, Inc.

K number K860984

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CEP 1986-04-21

VISI-CHECK HLH TEST MONOCLONAL

Applicant Bioclinical Systems, Inc.

K number K860334

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CEP 1986-04-21

MICRO-ELISA HLH TEST KIT MONOCLONAL

Applicant Bioclinical Systems, Inc.

K number K860333

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