Radioimmunoassay, Prolactin (Lactogen)

FDA product code CFT · 80 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1625
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-12 – 1997-06-24

CFT 1997-06-24

PROLACTIN (PRL) HORMONE MICROPLATE ELISA

Applicant Monobind

K number K971921

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CFT 1997-02-25

VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K970281

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CFT 1997-02-20

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

Applicant Sealite Sciences, Inc.

K number K970188

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CFT 1997-01-21

ELECSYS PROLACTIN ASSAY

Applicant Boehringer Mannheim Corp.

K number K964748

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CFT 1996-04-26

DSL ACTIVE PROLACTIN ELISA MODEL 10-4500

Applicant Diagnostic Systems Laboratories, Inc.

K number K960561

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CFT 1996-02-29

DSL ACTIVE PROLACTIN IRMA

Applicant Diagnostic Systems Laboratories, Inc.

K number K960060

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CFT 1995-10-20

ACCESS PROLACTIN ASSAY (MODIFICATION)

Applicant Bio-Rad Laboratories, Inc.

K number K954680

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CFT 1995-10-03

ABBOTT IMX PROLACTIN(MODIFICATION)

Applicant Abbott Mfg., Inc.

K number K953656

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CFT 1995-09-25

ABBOTT AXSYM PROLACTIN(MODIFICATION)

Applicant Abbott Mfg., Inc.

K number K953657

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CFT 1995-03-21

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1

Applicant Organon Teknika Corp.

K number K944698

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CFT 1994-11-02

ENZYME-LINKED FLUORESCENT IMMUNOASSAY

Applicant Biomerieux Vitek, Inc.

K number K943811

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CFT 1994-06-21

AXSYM PROLACTIN

Applicant Abbott Laboratories

K number K935675

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CFT 1994-06-03

DUPONT ACA PLUS PROLACTIN (PROL) METHOD

Applicant Dupont Medical Products

K number K941220

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CFT 1994-06-02

ACCESS PROLACTIN

Applicant Bio-Rad Laboratories, Inc.

K number K941175

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CFT 1993-08-19

COBAS CORE PROLACTIN EIA

Applicant Roche Diagnostic Systems, Inc.

K number K930305

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CFT 1993-03-29

VISTA PROLACTIN ASSAY

Applicant Syva Co.

K number K926386

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CFT 1993-03-05

IMMULITE PROLACTIN

Applicant Diagnostic Products Corp.

K number K925846

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CFT 1992-10-05

IMMUCHEM PRL-MW ELISA

Applicant Icn Biomedicals, Inc.

K number K922715

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CFT 1992-09-02

AMERLITE PROLACTIN-30 ASSAY

Applicant Eastman Kodak Company

K number K922170

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CFT 1992-04-08

ELISA TUBE PROLACTIN TEST KIT

Applicant Bio Clinic Co.

K number K920921

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CFT 1992-03-18

PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)

Applicant Medix Biotech, Inc.

K number K920345

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CFT 1992-02-18

AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

Applicant Amersham Corp.

K number K914135

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CFT 1991-09-30

PROLACTIN IRMA IMMUNOMAG

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K914107

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CFT 1991-08-16

OPUS(R) PROLACTIN TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K913280

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CFT 1990-11-07

CIBA CORNING ACS PROLACTIN IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K904714

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CFT 1990-11-05

ELEGANCE PROLACTIN ELISA

Applicant Bioclone Australia Pty , Ltd.

K number K904483

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CFT 1990-10-12

LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION

Applicant London Diagnostics, Inc.

K number K904458

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CFT 1990-07-19

AFFINITY PROLACTIN TEST SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K902698

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CFT 1990-06-12

PROLACTIN (LACTOGEN) TEST SYSTEM

Applicant Baxter Healthcare Corp

K number K901673

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CFT 1990-04-19

COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2

Applicant Diagnostic Products Corp.

K number K901578

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CFT 1990-03-30

ENZYMUN TEST(R) PROLACTIN

Applicant Boehringer Mannheim Corp.

K number K900695

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CFT 1990-01-19

ABBOTT IMX PROLACTIN

Applicant Abbott Laboratories

K number K896162

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CFT 1989-12-27

MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K896641

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CFT 1989-10-17

SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K895380

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CFT 1989-10-12

CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K894988

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CFT 1989-09-18

MILENIA(TM) PROLACTIN (MKPR1,5)

Applicant Diagnostic Products Corp.

K number K895003

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CFT 1988-11-01

AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)

Applicant Amersham Corp.

K number K883878

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CFT 1988-11-01

IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES

Applicant Diagnostic Products Corp.

K number K883747

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CFT 1988-09-13

PRL-QUANT

Applicant Leeco Diagnostics, Inc.

K number K883269

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CFT 1988-06-08

PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K881774

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CFT 1988-03-24

LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY

Applicant London Diagnostics, Inc.

K number K880296

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CFT 1988-03-01

BINAX PROLACTIN IRMA DIAGNOSTIC KIT

Applicant Binax, Inc.

K number K880218

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CFT 1988-01-11

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201

Applicant Cyberfluor, Inc.

K number K874621

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CFT 1987-10-09

MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT

Applicant Medix Biotech, Inc.

K number K873355

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CFT 1987-09-25

PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA

Applicant Serono Diagnostics, Inc.

K number K873400

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CFT 1987-09-18

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS

Applicant Serono Diagnostics, Inc.

K number K872862

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CFT 1987-05-14

HPROLACTIN KIT

Applicant Immuchem Corp.

K number K871542

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CFT 1987-01-21

BECKMAN EPSILON(TM) PROLACTIN TEST KIT

Applicant Beckman Instruments, Inc.

K number K864439

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CFT 1986-12-16

UBI MAGIWEL(TM) PROLACTIN QUANTATIVE

Applicant United Biotech, Inc.

K number K864075

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CFT 1986-11-21

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

Applicant Hybritech, Inc.

K number K863860

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CFT 1986-09-29

PROLACTIN RIABEAD II DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K863240

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CFT 1986-08-19

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT

Applicant Cis-Us, Inc.

K number K860823

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CFT 1986-06-27

SUCROSEP HUMAN PROLACTIN (HPR) IRMA

Applicant Boots-Celltech Diagnostics, Inc.

K number K861271

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CFT 1986-06-17

DELFIA (TM) HUMAN PROLACTIN

Applicant Lkb Instruments, Inc.

K number K861542

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CFT 1986-06-13

LEE-BEAD PROLACTIN (EIA)

Applicant Leeco Diagnostics, Inc.

K number K861945

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CFT 1986-03-05

ENCORE PROLACTIN REAGENT

Applicant Hybritech, Inc.

K number K860221

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CFT 1986-01-28

ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM

Applicant Nichols Institute Diagnostics

K number K854805

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CFT 1986-01-13

TERUMO SENSIBEAD EIA HPRL KIT

Applicant Terumo Medical Corp.

K number K854768

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CFT 1985-04-29

PROLACTIN SYSTEM BY RIA

Applicant American Bioclinical, Inc.

K number K851330

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CFT 1985-03-01

PRL QUIK RIA KIT

Applicant Pacific Biotech, Inc.

K number K850383

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CFT 1984-11-13

TANDEM - EPRL

Applicant Hybritech, Inc.

K number K843804

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CFT 1984-09-14

PROLACTIN IRMA

Applicant Euro-Diagnostics BV

K number K842478

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CFT 1984-05-11

PROLACTIN RIABEAD PROLACTIN RADIOIMM

Applicant Abbott Laboratories

K number K841118

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CFT 1984-01-24

COAT-A-COUNT NHS-PROLACTIN KIT AND

Applicant Diagnostic Products Corp.

K number K833925

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CFT 1983-06-08

RIANEN PROLACTIN 125I KIT

Applicant New England Nuclear

K number K831345

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CFT 1983-04-05

RADIOIMMUNOASSAY TEST SYSTEM PRL

Applicant Monobind

K number K830412

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CFT 1982-12-22

RIASET PROLACTIN RIA KIT

Applicant Immulok, Inc.

K number K823304

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CFT 1982-10-21

ABBOTT LABORATORIES PROLACTIN EIA

Applicant Abbott Laboratories

K number K822759

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CFT 1982-06-11

TANDEM PROLACTIN KIT

Applicant Hybritech, Inc.

K number K821545

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CFT 1982-05-24

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K821305

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CFT 1982-03-26

CENTRIA PROLACTIN TEST SET

Applicant Ventrex Laboratories, Inc.

K number K813572

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CFT 1982-01-22

LEECO PRL-QUANT DIAGNOSTIC TEST KIT

Applicant Leeco Diagnostics, Inc.

K number K820039

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CFT 1981-08-13

MARRIA-HPRL RIA KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K number K812112

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CFT 1981-07-10

MRI PROLACTIN RIA KIT

Applicant Microanalytic Research, Inc.

K number K810949

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CFT 1981-01-16

PROLACTIN (125) RADIOIMMUNAOASSAY

Applicant Corning Medical & Scientific

K number K803273

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CFT 1980-09-16

LACTI-QUANT

Applicant Nuclear Medical Laboratories, Inc.

K number K801849

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CFT 1980-07-08

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

Applicant Travenol Laboratories, S.A.

K number K801020

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CFT 1980-04-16

PROLACTIN RIA KIT

Applicant Amersham Corp.

K number K800740

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CFT 1979-11-13

125 I PROLACTIN HORMONE RIA KIT

Applicant Diagnostic Products Corp.

K number K792166

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CFT 1979-03-12

RIA KIT, PROLACTIN

Applicant Cis Radiopharmaceuticals, Inc.

K number K790003

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