FDA 510(k) Applications for Medical Device Product Code "CEO"
(Phosphomolybdate (Colorimetric), Inorganic Phosphorus)

FDA 510(k) Number Applicant Device Name Decision Date
K991867 A.P. TOTAL CARE, INC. INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 08/02/1999
K022312 ABAXIS, INC. PICCOLO PHOSPHORUS TEST SYSTEM 09/05/2002
K863088 ABBOTT LABORATORIES ABBOTT SPECTRUM PHOSPHORUS REAGENT 09/25/1986
K981118 ABBOTT LABORATORIES PHOS 06/12/1998
K981759 ABBOTT LABORATORIES PHOS 06/16/1998
K781000 ABBOTT LABORATORIES PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS 12/04/1978
K850380 ADVANCED BIOMEDICAL METHODS, INC. INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER 03/01/1985
K072141 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S40 CLINICAL ANALYZER, S TEST IP, S TEST UA 06/24/2008
K852003 ALPKEM CORP. IP ACID REAGENT IP MOLY BDATE REAGENT 05/31/1985
K833002 AMERICAN DADE PARAMAX PHOSPHORUS REAGENT 10/14/1983
K895999 AMERICAN MONITOR CORP. PHOSPHORUS 01/11/1990
K861968 AMERICAN RESEARCH PRODUCTS CO. AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET 06/13/1986
K900977 AMERICAN RESEARCH PRODUCTS CO. AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 04/11/1990
K871321 AMERICAN RESEARCH PRODUCTS CO. FLOW-PAC INORGANIC PHOSPHORUS REAGENTS 04/22/1987
K901964 AMERICAN RESEARCH PRODUCTS CO. PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 05/31/1990
K813400 ANCO MEDICAL REAGENTS & ASSOC. INORGANIC PHOSPHORUS REAGENT SET 12/22/1981
K873454 BAXTER HEALTHCARE CORP. PARAMAX PHOSPHORUS REAGENT 11/23/1987
K891218 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ/QCA PHOSPHORUS 03/22/1989
K041643 BECKMAN COULTER, INC. SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT 08/18/2004
K841181 BECKMAN INSTRUMENTS, INC. ASTRA SYS INORGANIC PHOSPHORUS CHEM 05/09/1984
K910296 BIOCHEMICAL TRADE, INC. PHOSPHORUS (INORGANIC) TEST SYSTEM 02/27/1991
K885041 BIOTROL, USA, INC. BIOTROL INORGANIC PHOSPHORUS 01/30/1989
K983503 BOEHRINGER MANNHEIM CORP. ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 12/01/1998
K981610 CARESIDE, INC. CARESIDE ANALYZER 06/25/1998
K971363 CAROLINA LIQUID CHEMISTRIES CORP. SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT 04/21/1997
K874472 CATACHEM, INC. INORGANIC PHOSPHORUS 12/22/1987
K854188 CLINICAL DATA, INC. IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO 11/25/1985
K900215 COULTER CORP. COULTER PHOSPHORUS REAGENT 02/08/1990
K850986 DATA MEDICAL ASSOCIATES, INC. DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE 04/01/1985
K861661 DATA MEDICAL ASSOCIATES, INC. INORGANIC PHOSPHORUS PROCEDURE 07/01/1986
K863264 DATA MEDICAL ASSOCIATES, INC. INORGANIC PHOSPHORUS PROCEDURE 09/11/1986
K955937 DERMA MEDIA LAB., INC. INORGANIC PHOSPHORUS REAGENT 03/12/1996
K974858 DIAGNOSTIC CHEMICALS LTD. PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 01/30/1998
K843030 DIAGNOSTIC CHEMICALS, LTD. (USA) INORGANIC PHOSPHORUS ASSAY KIT 08/27/1984
K862834 DIAGNOSTIC CHEMICALS, LTD. (USA) MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT 08/19/1986
K800690 DIAGNOSTIC SOLUTIONS, INC. REAGENT FOR DETERM. INORGANIC/PHOSPHORUS 05/28/1980
K850934 DILAB, INC. PHOSPHORUS 06/25/1985
K760634 E.I. DUPONT DE NEMOURS & CO., INC. ACA PHOSPHORUS ANALYTICAL TEST PACK 11/24/1976
K932729 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) 08/03/1993
K874577 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (PHOS) 01/21/1988
K030015 ELAN DIAGNOSTICS ATAC PAK PHOSPHORUS REAGENT 03/07/2003
K981769 ELAN PHARMA, INC. HICHEM PHOSPHORUS REAGENT KIT 06/29/1998
K912809 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 08/12/1991
K874153 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 11/04/1987
K935178 EM DIAGNOSTIC SYSTEMS, INC. EMDS PHOSPHOROUS (PHOS) TEST 12/17/1993
K863718 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 10/29/1986
K903696 EM DIAGNOSTIC SYSTEMS, INC. OLYMPUS INORGANIC PHOSPHORUS 09/12/1990
K901807 EM DIAGNOSTIC SYSTEMS, INC. OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) 05/02/1990
K884735 EM DIAGNOSTIC SYSTEMS, INC. PHOSPHORUS TEST (PHOS) ITEM #65666 12/16/1988
K843330 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE PHOSPHORUS 67217 09/14/1984
K923764 EM DIAGNOSTIC SYSTEMS, INC. SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 09/22/1992
K924470 EM DIAGNOSTIC SYSTEMS, INC. TWO PART INORGANIC PHOSPHORUS TEST 10/14/1992
K945368 EMD CHEMICALS INC. PHOSPHORUS TEST (PHOS) 12/02/1994
K945322 EMD CHEMICALS INC. PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 12/07/1994
K790021 FISHER SCIENTIFIC CO., LLC. SERUM, INORGANIC PHOSPHOROUS 02/15/1979
K771835 GAMMA ENTERPRISES, INC. INORGANIC PHOSPHORUS 11/02/1977
K791708 GILFORD DIAGNOSTICS INORGANIC PHOSPHORUS REAGENT 09/24/1979
K761238 HARLECO AUTO-INORGANIC PHOSPHORUS REAGENT 12/29/1976
K761239 HARLECO AUTO-INORGANIC PHOSPHORUS REAGENT 12/29/1976
K760030 HARLECO CLINICARD PHOSPHORUS 09/13/1976
K770820 HARLECO ULTRACHEM INORGANIC PHOSPHORUS 07/11/1977
K772156 HARLECO ULTRACHEM PHOSPHORUS, 64973 12/06/1977
K821874 HARLECO DIAGNOSTICS ULTRACHEM PHOS 07/13/1982
K003012 HEMAGEN DIAGNOSTICS, INC. RAICHEM PHOSPORUS REAGENT 10/25/2000
K890773 HICHEM DIAGNOSTICS HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 04/18/1989
K823580 HOFFMANN-LA ROCHE, INC. COBAS REAGENT FOR INORGANIC PHOSPHORUS 01/07/1983
K770456 ICN PHARMACEUTICALS, INC. PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT 05/03/1977
K931361 INSTRUMENTATION LABORATORY CO. IL TEST PHOSPHORUS 05/11/1993
K771477 INSTRUMENTATION LABORATORY CO. MULTISTAT III PHOSPHOROUS TEST 09/12/1977
K863072 J. D. ASSOC. FOSFOROMETER 09/09/1986
K003912 JAS DIAGNOSTICS, INC. PHOSPHORUS REAGENT 02/21/2001
K811749 KING DIAGNOSTICS, INC. KING DIAGNOSTICS PHOSPHORUS TEST 07/10/1981
K844182 LIVONIA DIAGNOSTICS, INC. INORGANIC PHOSPHORUS REAGENT SET 11/09/1984
K771848 MALLINCKRODT CRITICAL CARE PHOSPHORUS TEST KIT 10/28/1977
K852103 MEDICAL ANALYSIS SYSTEMS, INC. INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN 05/31/1985
K841061 MEDICAL SPECIALTIES, INC. PHOPHORUS REAGNET SET 05/01/1984
K944768 OLYMPUS AMERICA, INC. OLYMPUS INORGANIC PHOSPHORUS REAGENT 03/24/1995
K923564 OLYMPUS CORP. OLYMPUS INORGANIC PHOSPHORUS REAGENT 08/18/1992
K925057 OLYMPUS CORP. OLYMPUS INORGANIC PHOSPHORUS REAGENT 11/19/1992
K931835 OLYMPUS CORP. OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT 09/08/1993
K823691 OMEGA MEDICAL ELECTRONICS PHOSPHORUS REAGENT SET 01/07/1983
K802159 PANMED, INC. AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS 10/10/1980
K822470 POINTE SCIENTIFIC, INC. PSI INORGANIC PHOSPHORUS 09/14/1982
K942960 PRISMA SYSTEMS PHOSPHATE QVET 12/09/1994
K974605 RANDOX LABORATORIES, LTD. RANDOX INORGANIC PHOSPHOROUS 01/09/1998
K844316 REAGENTS APPLICATIONS, INC. RAICHEM PHOSPHORUS REAGENT 01/03/1985
K870776 REAGENTS APPLICATIONS, INC. RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT 03/13/1987
K883962 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR INORGANIC PHOSPHORUS 11/29/1988
K800297 SANDARE CHEMICAL CO., INC. SANDARE FAST 340 PHOSPHOROUS PROCEDURE 03/05/1980
K843177 SCLAVO, INC. INORGANIC PHOSPHORUS TEST 09/14/1984
K840215 SCLAVO, INC. PHOSPHORUS REAGENT SYSTEM 03/19/1984
K100263 SEPPIM S.A.S. ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS 05/06/2011
K781806 SIGMA CHEMICAL CO. REAGENT SYSTEM, INORGANIC PHOSPHORUS 01/17/1979
K874038 SIMMLER, INC. MULTICHEM INORGANIC PHOSPHOROUS S0923 10/28/1987
K860628 STERLING DIAGNOSTICS, INC. INORGANIC PHOSPHORUS REAGENT SET 03/14/1986
K912569 SYNERMED, INC. SYNERMED PHOSPHORUS REAGENT KIT 07/17/1991
K915708 TECH INTL. CO. INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET 01/22/1992
K881171 TECH-CO, INC. PHOSPHORUS (INORGANIC) 04/28/1988
K880676 TECH-NEAL SCIENTIFIC, INC. INORGANIC PHOSPHORUS REAGENT SET 03/24/1988
K901137 TECHNICON INSTRUMENTS CORP. CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) 04/12/1990
K855154 TECHNOSTICS INTL. INORGANIC PHOSPHORUS REAGENT SET 01/14/1986
K870368 TRACE SCIENTIFIC LTD. PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION 08/19/1987
K792401 VOLU SOL MEDICAL INDUSTRIES ELVI INORGANIC PHOSPHOROUS 12/07/1979
K013095 WIENER LABORATORIES S.A.I.C. WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 11/16/2001
K760990 WORTHINGTON BIOCHEMICAL CORP. INORGANIC PHOSPHOROUS REAGENT 11/16/1976


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