FDA 510(k) Applications for Medical Device Product Code "CGI"
(Radioimmunoassay, Estriol)

FDA 510(k) Number Applicant Device Name Decision Date
K844511 ABBOTT LABORATORIES TDX TOTAL ESTRIOL 01/18/1985
K810667 AMERSHAM CORP. AMERLEX ESTRIOL RIA KIT 03/31/1981
K844408 AMERSHAM CORP. AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED 12/11/1984
K800036 AMERSHAM CORP. TOTAL ESTRIOL RIA KIT 01/21/1980
K772215 AMERSHAM CORP. UNCONJUGATED ESTRIOL RIA KIT 12/22/1977
K811371 ARMKEL, LLC. NATAL-TEC ESTRIOL 05/29/1981
K974721 BAYER CORP. UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) 03/03/1998
K801735 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ARIA II 125- I-ESTRIOL SYSTEM 09/16/1980
K770465 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RIA-120 AND ESTRIOL REAGENT SYSTEM 06/02/1977
K802944 BIO-RAD QUANTIMUNE E3 RIA 12/22/1980
K811709 BIO-RAD QUANTIMUNE ESTRIOL RIA 07/10/1981
K820728 BIO-RAD QUANTIMUNE ESTRIOL RIA 04/06/1982
K781850 BIO-RAD RIA, QUANTIMUNE E3 01/03/1979
K844767 BIOTECX LABORATORIES, INC. RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO 02/01/1985
K811380 CAMBRIDGE NUCLEAR CORP. ESTRIOL KIT 06/09/1981
K790008 CAMBRIDGE NUCLEAR CORP. I ESTRIOL 02/26/1979
K781938 CLINICAL ASSAYS, INC. RIA KIT, GAMMADAB ESTRIOL 01/10/1979
K812768 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT FREE & TOTAL ESTRIOL KIT 01/18/1982
K932989 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT FREE ESTRIOL 12/19/1994
K823202 DIAGNOSTIC PRODUCTS CORP. FREE & TOTAL ESTRIOL KIT 12/15/1982
K830816 DIAGNOSTIC SYSTEMS DSL 1900 04/12/1983
K955356 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL 05/15/1996
K962875 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA 08/23/1996
K822314 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL 1400 09/30/1982
K802455 E. R. SQUIBB & SONS, INC. ESTRIOL-SQUIBB RIA KIT 10/31/1980
K920576 EASTMAN KODAK COMPANY AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL 03/23/1992
K781546 IMMUNALYSIS CORPORATION DIRECT ESTRIOL RIA KIT 12/04/1978
K840902 IMMUNOTECH CORP. ENDAB ESTRIOL UNCONJUGATED 04/18/1984
K903359 IMMUNOTECH CORP. MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT 08/22/1990
K802754 MICROANALYTIC RESEARCH, INC. IMMUNOREACTIVE ESTRIOL RIA KIT 01/21/1981
K821678 MICROMEDIC SYSTEMS AUTOPAK ESTRIOL TEST DELIVERY SYSTEM 06/24/1982
K822578 MICROMEDIC SYSTEMS MICROMEDIC ESTRIOL RIA KIT 10/26/1982
K840301 NEW ENGLAND NUCLEAR RIANEN ESTRIOL RADIOIMMUNOASSAY KIT 03/30/1984
K772323 NEW ENGLAND NUCLEAR RIANEN ESTRIOL RIA KIT 01/05/1978
K850787 NMS PHARMACEUTICALS, INC. SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY 03/26/1985
K792189 NORDICLAB INTL. NORDICLAB TOTAL ESTRIOL RIA TEST 11/13/1979
K780016 PCL-RIA, INC. HUMAN FOLLICLE STIMULATING HORMONE 02/03/1978
K791728 RADIOASSAY SYSTEMS LABORATORIES, INC. RSL'S ASSAY PROCEDURE QUANTITATION 09/27/1979
K860900 SCLAVO, INC. IMMPULSE FREE ESTRIOL ASSAY REAGENTS 04/28/1986
K801424 SQUIBB & SONS, INC. ESTRIOL RIA KIT FOR USE WITH GAMMAFLO 07/21/1980
K944490 WALLAC OY AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT 12/09/1994
K781599 WIEN LABORATORIES, INC. I-ESTRIOL TEST SET 10/17/1978


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact