FDA 510(k) Applications for Medical Device Product Code "CIC"
(Cresolphthalein Complexone, Calcium)

FDA 510(k) Number Applicant Device Name Decision Date
K882586 A-KEM, INC. A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM 08/08/1988
K991111 A.P. TOTAL CARE, INC. BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 05/25/1999
K860425 ABBOTT LABORATORIES A-GENT LIQUID CALCIUM 04/03/1986
K894407 ABBOTT LABORATORIES ABBOTT SPECTRUM(R) CALCIUM REAGENT 09/25/1989
K863670 ABBOTT LABORATORIES VISION (TM) CALCIUM 11/13/1986
K844241 ADVANCED BIOMEDICAL METHODS, INC. CALCIUM REAGENT FOR DEMAND ANALYZER 01/03/1985
K844243 ADVANCED BIOMEDICAL METHODS, INC. TOTAL BILIRUBIN FOR DEMAND ANALYZER 01/03/1985
K852002 ALPKEM CORP. CA BUFFER CA DYE 06/25/1985
K832708 AMERICAN DADE PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS 10/14/1983
K852657 AMERICAN RESEARCH PRODUCTS CO. AMRESCO CALCIUM REAGENT SET 07/15/1985
K834336 AMERICAN RESEARCH PRODUCTS CO. FLOW-PAC CALCIUM REAGENT SET 02/21/1984
K823219 AMERICAN RESEARCH PRODUCTS CO. LIQUIZYME CALCIUM REAGENT SET 12/03/1982
K902479 AMRESCO, INC. CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 07/17/1990
K860664 AMRESCO, INC. CRESOLPHTHALEIN COMPLEXONE, CALCIUM 06/27/1986
K812835 ANCO MEDICAL REAGENTS & ASSOC. TOTAL CALCIUM REAGENT SET 10/09/1981
K050077 ARKRAY, INC. SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS 02/15/2005
K053401 ARKRAY, INC. SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS 03/24/2006
K873519 BAXTER HEALTHCARE CORP. PARAMAX CALCIUM REAGENT 12/14/1987
K891217 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ CALCIUM 05/03/1989
K802923 BECKMAN INSTRUMENTS, INC. BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY 12/19/1980
K884480 BIOTROL, USA, INC. BIOTROL BILIRUBIN MONOREACTIF 11/29/1988
K850281 BOEHRINGER MANNHEIM CORP. CALCIUM 02/06/1985
K872306 BOEHRINGER MANNHEIM CORP. SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) 08/18/1987
K871811 BOEHRINGER MANNHEIM CORP. SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) 05/26/1987
K971907 CAROLINA LIQUID CHEMISTRIES CORP. CALCIUM REAGENT 06/24/1997
K880308 CATACHEM, INC. CALCIUM 05/27/1988
K792337 CONNECTICUT DIAGNOSTICS, LTD. DONNECT. DIAG. CALCIUM DIAG. REAGENT 12/06/1979
K861657 DATA MEDICAL ASSOCIATES, INC. CALCIUM PROCEDURE 05/29/1986
K863256 DATA MEDICAL ASSOCIATES, INC. CALCIUM PROCEDURE 09/26/1986
K955939 DERMA MEDIA LAB., INC. CALCIUM REAGENT 03/13/1996
K842509 DIAGNOSTIC CHEMICALS, LTD. (USA) CALCIUM ASSAY KIT 07/20/1984
K874496 DIAGNOSTIC CHEMICALS, LTD. (USA) CALCIUM ASSAY KIT, NUMBER 120-19 02/11/1988
K881054 DIAGNOSTIC CHEMICALS, LTD. (USA) CALCIUM, CATALOGUE NUMBER 122-20 04/18/1988
K800680 DIAGNOSTIC SOLUTIONS, INC. REAGENTS FOR DETERM. CALCIUM IN HUMAN 05/28/1980
K850929 DILAB, INC. CALCIUM 06/10/1985
K862274 E.I. DUPONT DE NEMOURS & CO., INC. ANALYST ANALYTICAL TEST ROTORS 07/29/1986
K023105 ELAN DIAGNOSTICS ATAC CALCIUM REAGENT AND ATAC CALIBRATOR 03/13/2003
K932158 EM DIAGNOSTIC SYSTEMS, INC. CALCIUM TEST ITEM NUMBER 65409 09/27/1993
K893778 EM DIAGNOSTIC SYSTEMS, INC. CALCIUM TEST ITEM NUMBER: 65409 09/05/1989
K884986 EM DIAGNOSTIC SYSTEMS, INC. CALCIUM TEST ITEM NUMBER: SR1009 01/13/1989
K870170 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 03/06/1987
K863003 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) CALCIUM TESTPACKS, #67687/95 09/16/1986
K905659 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 01/15/1991
K843152 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE CALCIUM 67214 08/29/1984
K823756 EM INDUSTRIES, INC. ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 01/12/1983
K830238 EMD CHEMICALS INC. ULTRA CHEM CRESOLCAVERSACHEM #65082 02/18/1983
K912027 ENZYME TECHNOLOGY, INC. CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL 01/30/1992
K833035 FISHER SCIENTIFIC CO., LLC. CALCIUM DYE REAGENT-CS-718-A/BUFFER 11/03/1983
K771831 GAMMA ENTERPRISES, INC. CALCIUM 10/25/1977
K812110 GILFORD DIAGNOSTICS GILCHEM CALCIUM REAGENT 08/13/1981
K041009 HEMAGEN DIAGNOSTICS, INC. RAICHEM CALCIUM (OCPC) LIQUID REAGENT 06/25/2004
K923034 HERAEUS KULZER, INC. MILES URINE CALCIUM METHOD 09/15/1992
K820090 HI CHEM, INC. ASTRA-T CALCIUM REAGENT 01/28/1982
K130870 HITACHI CHEMICAL DIAGNOSTICS, INC. HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) 05/02/2013
K823577 HOFFMANN-LA ROCHE, INC. COBAS REAGENT FOR CALCIUM 01/07/1983
K070249 HORIBA ABX ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H 04/26/2007
K760468 HYCEL, INC. TEST, REFORMULATED HYCEL HMA CALCIUM 11/01/1976
K770449 ICN PHARMACEUTICALS, INC. CALCIUM PROCEDURE, TEKPOINT DIRECT 05/03/1977
K931362 INSTRUMENTATION LABORATORY CO. IL TEST CALCIUM 02/01/1994
K811748 KING DIAGNOSTICS, INC. KING DIAGNOSTICS CALCIUM TEST 07/10/1981
K843895 LIVONIA DIAGNOSTICS, INC. TOTAL CALCIUM REAGENT SET 10/30/1984
K771310 MALLINCKRODT CRITICAL CARE CALCIUM REAGENT 08/03/1977
K855041 MEDICAL ANALYSIS SYSTEMS, INC. CALCIUM LIQUID STABLE REAGENT SET 01/22/1986
K841051 MEDICAL SPECIALTIES, INC. SERUM CALCIUM REAGENT SET 05/01/1984
K854716 NOBEL SCIENTIFIC INDUSTRIES, INC. NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 01/07/1986
K944258 OLYMPUS AMERICA, INC. CALCIUM REAGENT 01/05/1995
K922233 OLYMPUS CORP. OLYMPUS CALCIUM REAGENT 07/10/1992
K924435 OLYMPUS CORP. OLYMPUS CALCIUM REAGENT 10/19/1992
K821196 OMEGA MEDICAL ELECTRONICS SERUM CALCIUM REAGENT SET 07/13/1982
K802164 PANMED, INC. 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. 10/10/1980
K921625 POINTE SCIENTIFIC, INC. CALCIUM-ARSENAZO III REAGENT SET 05/13/1992
K874131 POINTE SCIENTIFIC, INC. CRESOLPHTHALEIN COMPLEXONE, CALCIUM 12/04/1987
K822469 POINTE SCIENTIFIC, INC. PSI CALCIUM REAGENT 09/14/1982
K000375 RANDOX LABORATORIES, LTD. RANDOX CALCIUM 04/05/2000
K843353 REAGENTS APPLICATIONS, INC. RAICHEM CALCIUM REAGENT 09/20/1984
K963292 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS 10/31/1996
K896224 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY CALCIUM REAGENT 08/17/1990
K832183 SANDARE CHEMICAL CO., INC. SANDARE CALCIUM PROCEDURE 08/24/1983
K870629 SCLAVO, INC. CALCIUM TEST 04/29/1987
K864661 SCLAVO, INC. UNIFAST CALCIUM TEST 02/04/1987
K083339 Siemens Healthcare Diagnostics Inc. DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) 03/09/2009
K780983 SIGMA CHEMICAL CO. CALCIUM REAGENT SYSTEM NO. 585 07/27/1978
K871152 SIGMA DIAGNOSTICS, INC. SIGMA'S CALCIUM PROCEDURE NO. 587 06/12/1987
K760475 SIMMLER & SON, INC. REAGENT, CALCIUM DETERMINATION 10/29/1976
K853050 SIMMLER, INC. CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ 08/02/1985
K873697 SIMMLER, INC. MULTICHEM CALCIUM S0910 10/02/1987
K860044 STERLING DIAGNOSTICS, INC. CALCIUM (CPC) REAGENT SET 02/11/1986
K903233 SYNERMED, INC. SYNERMED CALCIUM REAGENT KIT 10/04/1990
K864741 TECH-CO, INC. CRESOLPHTHALEIN COMPLEXONE, CALCIUM 01/09/1987
K880845 TECH-NEAL SCIENTIFIC, INC. CALCIUM REAGENT SET 04/05/1988
K901226 TECHNICON INSTRUMENTS CORP. CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) 04/19/1990
K884433 TECHNICON INSTRUMENTS CORP. TECHNICON ASSIST(R) CALCIUM METHOD 11/29/1988
K884599 TECHNICON INSTRUMENTS CORP. TECHNICON RA-100 SYSTEM CALCIUM METHOD 01/27/1989
K903896 TRACE SCIENTIFIC LTD. CALCIUM ARSENAZO III REAGENT 09/13/1990
K870362 TRACE SCIENTIFIC LTD. CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD 08/21/1987
K770460 UNION CARBIDE CORP. CENTRIFI CHEM CALCIUM REAGENT 06/02/1977
K820241 WAKO CHEMICALS, USA, INC. WAKO CALCIUM C TEST 02/12/1982
K873334 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT CALCIUM 10/02/1987
K013652 WIENER LABORATORIES S.A.I.C. WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 12/21/2001


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