FDA 510(k) Applications for Medical Device Product Code "CIX"
(Bromcresol Green Dye-Binding, Albumin)

FDA 510(k) Number Applicant Device Name Decision Date
K882587 A-KEM, INC. A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM 08/08/1988
K770822 ABBOTT LABORATORIES A-GENT ALBUMIN 07/11/1977
K981468 ABBOTT LABORATORIES ALBG 05/27/1998
K981758 ABBOTT LABORATORIES ALBG 06/12/1998
K853978 ABBOTT LABORATORIES TDX AMYLASE 10/15/1985
K844330 ADVANCED BIOMEDICAL METHODS, INC. ALBUMIN REAGENT FOR DEMAND ANALYZER 01/03/1985
K113374 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT 07/13/2012
K072143 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S40 CLINICAL ANALYZER, S TEST ALB 07/14/2008
K131488 ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT 08/19/2013
K852007 ALPKEM CORP. ALB BCG REAGENT 05/30/1985
K840782 AMERICAN DADE ALBUMIN REAGENT 04/13/1984
K860661 AMRESCO, INC. AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT 03/14/1986
K830536 AMRESCO, INC. FLOW-PAC ALBUMIN REAGENT 03/24/1983
K781441 ANALYTICAL & RESEARCH CHEMICALS, INC. BCG ALBUMIN REAGET 10/10/1978
K010877 AWARENESS TECHNOLOGY, INC. CHEMWELL, MODEL 2900 05/23/2001
K991576 BAYER CORP. ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM 06/30/1999
K992399 BAYER CORP. ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM 09/15/1999
K891375 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ ALBUMIN 05/05/1989
K801750 BECKMAN INSTRUMENTS, INC. BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY 09/16/1980
K860213 BIO-ANALYTICS LABORATORIES, INC. ALBUMIN REAGENT KIT 02/11/1986
K832747 BIORENT DIAGNOSTIC, INC. ALBUMIN REAGENT SET 10/14/1983
K170901 BioSystems S.A. ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 04/13/2018
K885094 BIOTROL, USA, INC. BIOTROL ALBUMIN 02/10/1989
K971445 CAROLINA LIQUID CHEMISTRIES CORP. ALB OR ALBUMIN 05/02/1997
K874163 CATACHEM, INC. ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS 11/23/1987
K854181 CLINICAL DATA, INC. IN-VITRO TEST DETERMINATION OF ALBUMIN 11/25/1985
K792339 CONNECTICUT DIAGNOSTICS, LTD. CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN 12/06/1979
K901268 COULTER CORP. COULTER ALBUMIN REAGENT 05/30/1990
K861654 DATA MEDICAL ASSOCIATES, INC. ALBUMIN PROCEDURE 06/13/1986
K863263 DATA MEDICAL ASSOCIATES, INC. ALBUMIN PROCEDURE 09/15/1986
K946355 DATA MEDICAL ASSOCIATES, INC. DMA ALBUMIN PROCEDURE 03/01/1995
K955781 DERMA MEDIA LAB., INC. ALBUMIN 03/13/1996
K843104 DIAGNOSTIC CHEMICALS, LTD. (USA) ALBUMIN ASSAY KIT 09/07/1984
K875207 DIAGNOSTIC CHEMICALS, LTD. (USA) ALBUMIN CAT. # 201-03 04/18/1988
K800678 DIAGNOSTIC SOLUTIONS, INC. REAGENTS FOR DETERM. ALBUMIN IN HUMAN 05/28/1980
K850931 DILAB, INC. ALBUMIN 06/26/1985
K812030 EASTMAN KODAK COMPANY KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) 08/03/1981
K913195 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (ALB) 08/26/1991
K030006 ELAN DIAGNOSTICS ATAC PAK ALBUMIN REAGENT 03/07/2003
K110830 ELITECHGROUP ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH 06/21/2011
K913920 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 09/27/1991
K923959 EM DIAGNOSTIC SYSTEMS, INC. ALBUMIN TEST 12/28/1992
K884705 EM DIAGNOSTIC SYSTEMS, INC. ALBUMIN TEST (ALB) ITEM #65650 01/11/1989
K893777 EM DIAGNOSTIC SYSTEMS, INC. ALBUMIN TEST (ALB) ITEM NUMBER: 65401 08/21/1989
K873994 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 10/29/1987
K864715 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 12/31/1986
K935179 EM DIAGNOSTIC SYSTEMS, INC. EMDS ALBUMIN (ALB) TEST 12/17/1993
K843108 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE ALBUMIN 08/27/1984
K905660 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 01/25/1991
K980041 EXIGENT DIAGNOSTICS, INC. CARESIDE ALBUMIN 02/04/1998
K833699 FISHER SCIENTIFIC CO., LLC. ALBUMIN REAGENT CS-716 01/13/1984
K760543 FISHER SCIENTIFIC CO., LLC. BROMCRESOL GREEN 11/01/1976
K771828 GAMMA ENTERPRISES, INC. ALBUMIN 10/25/1977
K781773 GILFORD DIAGNOSTICS ALBUMIN REAGENT 11/22/1978
K761028 HARLECO AUTO-ALBUMIN REAG FOR ABBOTT ABA-100 11/30/1976
K813044 HARLECO ULTRACHEM ALB, ITEM #64970 11/10/1981
K770816 HARLECO ULTRACHEM ALBUMIN 07/11/1977
K780092 HARLECO ULTRACHEM ALBUMIN 02/07/1978
K771094 HARLECO UNIPAK ALBUMIN 07/21/1977
K761026 HARLECO DIAGNOSTICS AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL 11/30/1976
K821880 HARLECO DIAGNOSTICS ULTRA CHEM ALB 07/14/1982
K821225 HI CHEM, INC. ALBUMIN REAGENT 05/21/1982
K823574 HOFFMANN-LA ROCHE, INC. COBAS REAGENT FOR ALBUMIN 01/07/1983
K823575 HOFFMANN-LA ROCHE, INC. COBAS STANDARDS FOR ALBUMIN 01/07/1983
K060434 HORIBA ABX ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL 06/05/2007
K771259 HYCEL, INC. ALBUMIN TEST, HMA ALBUMIN TEST 08/22/1977
K770451 ICN PHARMACEUTICALS, INC. ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL 05/03/1977
K771475 INSTRUMENTATION LABORATORY CO. MULTISTAT III ALBUMIN TEST 09/13/1977
K863050 J. D. ASSOC. ALBUMETER 09/11/1986
K003327 JAS Diagnostics, Inc. ALBUMIN 12/05/2000
K811662 KING DIAGNOSTICS, INC. ALBUMIN TEST 06/25/1981
K792482 LABORATORY PRODUCTS, INC. CHEMISTRY ANALYZER REAGENTS 01/11/1980
K843831 LIVONIA DIAGNOSTICS, INC. ALBUMIN REAGENT SET 10/11/1984
K760355 MALLINCKRODT CRITICAL CARE TEST, SEROSONIC ALBUMIN 10/05/1976
K080874 MEDICA CORP. EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT 02/20/2009
K101088 MEDICA CORP. EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT 04/04/2011
K853868 MEDICAL ANALYSIS SYSTEMS, INC. ALBUMIN SR LIQUID STABLE REAGENT SET 09/30/1985
K841063 MEDICAL SPECIALTIES, INC. ALBUMIN REAGENT SET 05/01/1984
K840291 MEDILAB CORP. MCS ALBUMIN REAGENT 03/30/1984
K896910 MILES DIAGNOSTICS DIV. CLINISTAT ALBUMIN REAGENT TEST 01/18/1990
K803237 MILES LABORATORIES, INC. AMES SERA-PAK ALBUMIN REAGENT KIT 01/09/1981
K854718 NOBEL SCIENTIFIC INDUSTRIES, INC. NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 12/19/1985
K011720 OLYMPUS AMERICA, INC. OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER 06/25/2001
K922369 OLYMPUS CORP. OLYMPUS ALBUMIN REAGENT 07/17/1992
K924368 OLYMPUS CORP. OLYMPUS ALBUMIN REAGENT 02/08/1993
K821193 OMEGA MEDICAL ELECTRONICS ALBUMIN REAGENT SET 07/13/1982
K023875 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4 12/10/2002
K802157 PANMED, INC. BCG REAGENT SERUM ALBUMIN W/TECHNICON 10/10/1980
K822471 POINTE SCIENTIFIC, INC. PSI ALBUMIN REAGENT 09/14/1982
K110818 POLYMEDCO, INC. POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS 09/08/2011
K022072 PRECISION SYSTEMS, INC. PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS 08/23/2002
K943000 PRISMA SYSTEMS ALBUMIN QVET 12/13/1994
K984494 RANDOX LABORATORIES, LTD. RANDOX ALBUMIN 03/23/1999
K831585 REAGENTS APPLICATIONS, INC. ALBUMIN REAGENT (BCG 06/16/1983
K896235 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY ALBUMIN REAGENT 02/27/1990
K033009 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 10/16/2003
K860684 SANDARE CHEMICAL CO., INC. SANDARE BCG ALBUMIN PROCEDURE 03/17/1986
K861467 SIGMA DIAGNOSTICS, INC. ALBUMIN (BCG) REAGENT 05/23/1986
K760473 SIMMLER & SON, INC. REAGENT, ALBUMIN DETERMINATION 10/29/1976
K853049 SIMMLER, INC. ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE 08/02/1985
K874049 SIMMLER, INC. MULTICHEM ALBUMIN REAGENT S0902 10/29/1987
K860340 STERLING DIAGNOSTICS, INC. SERUM ALBUMIN (BCG) REAGENT SET 02/19/1986
K903543 SYNERMED, INC. SYNERMED ALBUMIN REAGENT KIT 10/12/1990
K875070 TECH-CO, INC. ALBUMIN, BROMCRESOL GREEN DYE-BINDING 01/11/1988
K880844 TECH-NEAL SCIENTIFIC, INC. ALBUMIN REAGENT SET 04/05/1988
K851308 TECHNICON INSTRUMENTS CORP. ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S 04/17/1985
K761329 TECHNICON INSTRUMENTS CORP. MT II SYSTEM - SERUM ALBUMIN 03/21/1977
K914888 TECHNICON INSTRUMENTS CORP. TECHNICON CHEM 1(TM) SYST (GEN2 SYST) 11/27/1991
K855158 TECHNOSTICS INTL. ALBUMIN REAGENT SET 01/14/1986
K870372 TRACE SCIENTIFIC LTD. ALBUMIN REAGENT - BROMCRESOL GREEN METHOD 08/19/1987
K923322 TRACE SCIENTIFIC LTD. TRACE ALBUMIN-MR REAGENT 09/11/1992
K952488 TRACE SCIENTIFIC LTD. TRACE COBAS MIRA RANGE 10/13/1995
K802436 UNION CARBIDE CORP. CENTRIFICHEM ALBUMIN 10/31/1980
K792408 VOLU SOL MEDICAL INDUSTRIES ELVI ALBUMIN 12/06/1979
K880313 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT ALBUMIN 03/24/1988
K012329 WIENER LABORATORIES S.A.I.C. WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300 09/21/2001


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