FDA 510(k) Applications for Medical Device Product Code "CFT"
(Radioimmunoassay, Prolactin (Lactogen))

FDA 510(k) Number Applicant Device Name Decision Date
K896162 ABBOTT LABORATORIES ABBOTT IMX PROLACTIN 01/19/1990
K822759 ABBOTT LABORATORIES ABBOTT LABORATORIES PROLACTIN EIA 10/21/1982
K935675 ABBOTT LABORATORIES AXSYM PROLACTIN 06/21/1994
K863240 ABBOTT LABORATORIES PROLACTIN RIABEAD II DIAGNOSTIC KIT 09/29/1986
K841118 ABBOTT LABORATORIES PROLACTIN RIABEAD PROLACTIN RADIOIMM 05/11/1984
K953657 ABBOTT MFG., INC. ABBOTT AXSYM PROLACTIN(MODIFICATION) 09/25/1995
K953656 ABBOTT MFG., INC. ABBOTT IMX PROLACTIN(MODIFICATION) 10/03/1995
K851330 AMERICAN BIOCLINICAL, INC. PROLACTIN SYSTEM BY RIA 04/29/1985
K883878 AMERSHAM CORP. AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) 11/01/1988
K914135 AMERSHAM CORP. AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 02/18/1992
K800740 AMERSHAM CORP. PROLACTIN RIA KIT 04/16/1980
K901673 BAXTER HEALTHCARE CORP. PROLACTIN (LACTOGEN) TEST SYSTEM 06/12/1990
K902698 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY PROLACTIN TEST SYSTEM 07/19/1990
K821305 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PROLACTIN (125-I) RADIOIMMUNOASSAY KIT 05/24/1982
K881774 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM 06/08/1988
K864439 BECKMAN INSTRUMENTS, INC. BECKMAN EPSILON(TM) PROLACTIN TEST KIT 01/21/1987
K880218 BINAX, INC. BINAX PROLACTIN IRMA DIAGNOSTIC KIT 03/01/1988
K920921 BIO CLINIC CO. ELISA TUBE PROLACTIN TEST KIT 04/08/1992
K941175 BIO-RAD LABORATORIES, INC. ACCESS PROLACTIN 06/02/1994
K954680 BIO-RAD LABORATORIES, INC. ACCESS PROLACTIN ASSAY (MODIFICATION) 10/20/1995
K904483 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE PROLACTIN ELISA 11/05/1990
K943811 BIOMERIEUX VITEK, INC. ENZYME-LINKED FLUORESCENT IMMUNOASSAY 11/02/1994
K964748 BOEHRINGER MANNHEIM CORP. ELECSYS PROLACTIN ASSAY 01/21/1997
K900695 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) PROLACTIN 03/30/1990
K861271 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP HUMAN PROLACTIN (HPR) IRMA 06/27/1986
K904714 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS PROLACTIN IMMUNOASSAY 11/07/1990
K894988 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY 10/12/1989
K790003 CIS RADIOPHARMACEUTICALS, INC. RIA KIT, PROLACTIN 03/12/1979
K860823 CIS-US, INC. ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT 08/19/1986
K803273 CORNING MEDICAL & SCIENTIFIC PROLACTIN (125) RADIOIMMUNAOASSAY 01/16/1981
K874621 CYBERFLUOR, INC. FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 01/11/1988
K792166 DIAGNOSTIC PRODUCTS CORP. 125 I PROLACTIN HORMONE RIA KIT 11/13/1979
K833925 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT NHS-PROLACTIN KIT AND 01/24/1984
K901578 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 04/19/1990
K925846 DIAGNOSTIC PRODUCTS CORP. IMMULITE PROLACTIN 03/05/1993
K883747 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES 11/01/1988
K895003 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) PROLACTIN (MKPR1,5) 09/18/1989
K960561 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 04/26/1996
K960060 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE PROLACTIN IRMA 02/29/1996
K941220 DUPONT MEDICAL PRODUCTS DUPONT ACA PLUS PROLACTIN (PROL) METHOD 06/03/1994
K922170 EASTMAN KODAK COMPANY AMERLITE PROLACTIN-30 ASSAY 09/02/1992
K842478 EURO-DIAGNOSTICS BV PROLACTIN IRMA 09/14/1984
K860221 HYBRITECH, INC. ENCORE PROLACTIN REAGENT 03/05/1986
K843804 HYBRITECH, INC. TANDEM - EPRL 11/13/1984
K821545 HYBRITECH, INC. TANDEM PROLACTIN KIT 06/11/1982
K863860 HYBRITECH, INC. TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN 11/21/1986
K922715 ICN BIOMEDICALS, INC. IMMUCHEM PRL-MW ELISA 10/05/1992
K871542 IMMUCHEM CORP. HPROLACTIN KIT 05/14/1987
K823304 IMMULOK, INC. RIASET PROLACTIN RIA KIT 12/22/1982
K812112 INTL. IMMUNOASSAY LABORATORIES, INC. MARRIA-HPRL RIA KIT 08/13/1981
K970281 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS 02/25/1997
K861945 LEECO DIAGNOSTICS, INC. LEE-BEAD PROLACTIN (EIA) 06/13/1986
K820039 LEECO DIAGNOSTICS, INC. LEECO PRL-QUANT DIAGNOSTIC TEST KIT 01/22/1982
K883269 LEECO DIAGNOSTICS, INC. PRL-QUANT 09/13/1988
K861542 LKB INSTRUMENTS, INC. DELFIA (TM) HUMAN PROLACTIN 06/17/1986
K880296 LONDON DIAGNOSTICS, INC. LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY 03/24/1988
K904458 LONDON DIAGNOSTICS, INC. LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION 10/12/1990
K873355 MEDIX BIOTECH, INC. MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT 10/09/1987
K896641 MEDIX BIOTECH, INC. MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT 12/27/1989
K920345 MEDIX BIOTECH, INC. PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) 03/18/1992
K810949 MICROANALYTIC RESEARCH, INC. MRI PROLACTIN RIA KIT 07/10/1981
K971921 MONOBIND PROLACTIN (PRL) HORMONE MICROPLATE ELISA 06/24/1997
K830412 MONOBIND RADIOIMMUNOASSAY TEST SYSTEM PRL 04/05/1983
K831345 NEW ENGLAND NUCLEAR RIANEN PROLACTIN 125I KIT 06/08/1983
K854805 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM 01/28/1986
K801849 NUCLEAR MEDICAL LABORATORIES, INC. LACTI-QUANT 09/16/1980
K944698 ORGANON TEKNIKA CORP. AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 03/21/1995
K850383 PACIFIC BIOTECH, INC. PRL QUIK RIA KIT 03/01/1985
K914107 PANTEX, DIV. BIO-ANALYSIS, INC. PROLACTIN IRMA IMMUNOMAG 09/30/1991
K913280 PB DIAGNOSTIC SYSTEMS, INC. OPUS(R) PROLACTIN TEST SYSTEM 08/16/1991
K930305 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS CORE PROLACTIN EIA 08/19/1993
K970188 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE PROLACTIN 02/20/1997
K872862 SERONO DIAGNOSTICS, INC. PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS 09/18/1987
K873400 SERONO DIAGNOSTICS, INC. PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA 09/25/1987
K895380 SERONO-BAKER DIAGNOSTICS, INC. SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY 10/17/1989
K926386 SYVA CO. VISTA PROLACTIN ASSAY 03/29/1993
K854768 TERUMO MEDICAL CORP. TERUMO SENSIBEAD EIA HPRL KIT 01/13/1986
K801020 TRAVENOL LABORATORIES, S.A. GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- 07/08/1980
K864075 UNITED BIOTECH, INC. UBI MAGIWEL(TM) PROLACTIN QUANTATIVE 12/16/1986
K813572 VENTREX LABORATORIES, INC. CENTRIA PROLACTIN TEST SET 03/26/1982


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