FDA 510(k) Applications for Medical Device Product Code "CHP"
(Radioimmunoassay, Estradiol)

FDA 510(k) Number Applicant Device Name Decision Date
K920047 ABBOTT LABORATORIES IMX ESTRADIOL 02/18/1992
K884105 AMERSHAM CORP. AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) 11/16/1988
K896270 AMERSHAM CORP. AMERLITE ESTRADIOL-60 ASSAY "LAN.0081/2081" 12/12/1989
K933464 BAXTER DIAGNOSTICS, INC. STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY 10/22/1993
K910249 BAXTER HEALTHCARE CORP. STRATUS ESTRADIOL FLUOREMETRIC ENZYME 02/13/1991
K951360 BAYER CORP. ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM 05/02/1995
K973743 BECKMAN INSTRUMENTS, INC. ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER 10/31/1997
K931740 BIO-RAD COTUBE ESTRADIOL RADIOIMMUNOASSAY 08/16/1993
K970126 BIO-RAD LABORATORIES, INC. ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) 02/25/1997
K925498 BIOMERIEUX VITEK, INC. VIDAS ESTRADIOL (E2) ASSAY 02/12/1993
K955647 BIOMERIEUX VITEK, INC. VIDAS ESTRADIOL II (E2II) ASSAY 02/06/1996
K851540 BIOTECX LABORATORIES, INC. ESTRADIOL DIRECT RIA KIT 06/06/1985
K965109 BOEHRINGER MANNHEIM CORP. ELECSYS ESTRADIOL ASSAY 02/18/1997
K913162 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST ESTRADIOL 09/27/1991
K970386 CHIRON DIAGNOSTICS CORP. ACS ESTADIOL-6 II 06/04/1997
K932715 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS ESTRADIOL IMMUNOASSAY 12/03/1993
K954697 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS ESTRADIOL-6 ASSAY 12/13/1995
K840051 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT ESTRADIOL KIT 03/23/1984
K943193 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT(R) ESTRADIOL-6 02/23/1995
K862603 DIAGNOSTIC PRODUCTS CORP. DOUBLE ANTIBODY ESTRADIOL RIA KIT 08/19/1986
K932926 DIAGNOSTIC PRODUCTS CORP. IMMULITE ESTRADIOL 01/10/1994
K912917 DIAGNOSTIC PRODUCTS CORP. MILENIA ESTRADIOL 07/30/1991
K873550 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE ESTRADIOL RIA (DSL #4300) 02/18/1988
K870405 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) 06/08/1987
K953605 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ULTRA-SENSITIVE ESTRADIOL 10/02/1995
K041349 IBL GMBH LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM 09/24/2004
K820329 IMMUCHEM CORP. ESTRADIOL KIT BY RIA 03/04/1982
K970643 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) 03/18/1997
K973901 KMI DIAGNOSTICS, INC. 17 B-ESTRADIOL (ELISA) 11/24/1997
K834586 LEECO DIAGNOSTICS, INC. LEECO E2 QUANT DIAG. TEST KIT 03/09/1984
K800920 NORDICLAB INTL. NORDICLAB ESTRADIOL RIA TEST 05/14/1980
K946199 ORGANON TEKNIKA CORP. AURAFLEX(R) ESTRADIOL 04/03/1995
K810204 PANTEX, DIV. BIO-ANALYSIS, INC. 17B ESTRADIOL 03/27/1981
K853866 PANTEX, DIV. BIO-ANALYSIS, INC. PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS 10/15/1985
K933066 PB DIAGNOSTIC SYSTEMS, INC. OPUS ESTRADIOL 09/08/1993
K882173 PHARMACIA, INC. DELFIA ESTRADIOL KIT 06/24/1988
K902358 PHARMACIA, INC. MODIFIED DELFIA ESTRADIOL KIT 06/18/1990
K791652 RADIOASSAY SYSTEMS LABORATORIES, INC. ESTRADIOL KIT BY RIA 09/27/1979
K861361 SERONO DIAGNOSTICS, INC. ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE 06/27/1986
K790679 SERONO LABORATORIES, INC. ESTRADIOL RIA KIT 05/23/1979
K810695 SERONO LABORATORIES, INC. ESTRIOL RADIOIMMUNOASSAY TEST KIT 03/31/1981
K890645 SERONO-BAKER DIAGNOSTICS, INC. ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT 03/08/1989
K912318 SERONO-BAKER DIAGNOSTICS, INC. ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) 07/25/1991
K896145 SERONO-BAKER DIAGNOSTICS, INC. ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY 12/27/1989
K911396 SERONO-BAKER DIAGNOSTICS, INC. SR1 ESTRADIOL ENZYME IMMUNOASSAY 05/28/1991
K841947 SORIN BIOMEDICA, FIAT, USA, INC. ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT 06/25/1984
K882343 TERUMO MEDICAL CORP. TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT 07/01/1988
K932084 TOSOH MEDICS, INC. AIA-PACK E2 ASSAY 11/09/1993
K853208 TRAVENOL LABORATORIES, S.A. 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY 08/19/1985


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