FDA 510(k) Applications for Medical Device Product Code "CEE"
(Radioimmunoassay, Thyroxine-Binding Globulin)

FDA 510(k) Number Applicant Device Name Decision Date
K893469 AMERSHAM CORP. AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT 08/15/1989
K760134 BIO-RAD PROCEDURE, RA, THYROXINE BINDING PROTEIN 07/20/1976
K930010 BIO-RAD LABORATORIES, INC. ACCESS THYROID UPTAKE ASSAY 06/07/1993
K862109 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST TBG 06/30/1986
K896991 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) TBK 03/01/1990
K800204 BOEHRINGER MANNHEIM CORP. RIA PHASE TBG 03/19/1980
K910677 CIRRUS DIAGNOSTICS, INC. IMMULITE(TM) T-UPTAKE 04/29/1991
K810967 CLINICAL ASSAYS, INC. IN-VITRO TBG RADIOIMMUNOASSAY TEST 04/23/1981
K772183 CORNING MEDICAL & SCIENTIFIC THYROID BINDING GLOBULIN 12/20/1977
K884201 CYBERFLUOR, INC. FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT 12/14/1988
K820252 DIAGNOSTIC REAGENTS, INC. TBG DIAGNOSTIC KIT 05/05/1982
K885034 DIAMEDIX CORP. T-UPTAKE MICROASSAY 02/02/1989
K781225 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES GLOBULIN TEST, HUMAN THYROXINE BINDING 08/31/1978
K822684 IMMUNOTECH CORP. ENDAB THYROID UPTAKE 10/08/1982
K905777 IMMUNOTECH CORP. MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT 01/30/1991
K952284 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. AMERLITE TBG ASSAY 07/26/1995
K842010 NICHOLS INSTITUTE DIAGNOSTICS THYROXINE-BINDING GLOBULIN RADIOUMMU 06/25/1984
K771341 NUCLEAR DIAGNOSTICS, INC. SPINSEP-TBG 08/10/1977
K780486 NUCLEAR DIAGNOSTICS, INC. STIKSEP-T3 KIT 04/28/1978
K861735 NUCLEAR DIAGNOSTICS, INC. TIPSEP-TBG ASSAY 06/13/1986
K900240 PHARMACIA, INC. DELFIA TBG KIT 03/30/1990
K780671 RADIOIMMUNOASSAY, INC. 125 I-T3 UPTAKE REAGENT 06/06/1978
K842167 SYNCOR INTL. CORP. TBG RIA 07/09/1984
K874658 TECHNICON INSTRUMENTS CORP. TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) 12/18/1987
K841024 VENTREX LABORATORIES, INC. VENTREZYME T4U IMMUNOASSAY T4U 05/09/1984


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