Product Code: CEO FDA class 1 21 CFR 862.1580

Phosphomolybdate (Colorimetric), Inorganic Phosphorus

Clinical Chemistry

The Phosphomolybdate Colorimetric Inorganic Phosphorus Test is a clinical chemistry device that measures inorganic phosphorus levels in blood or urine using the phosphomolybdate colorimetric method, in which phosphate reacts with ammonium molybdate to form a colored complex, used in the evaluation of phosphate metabolism, renal function, and parathyroid disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEO, regulated under 21 CFR 862.1580, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

105

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CEO
Device Class: FDA class 1
Regulation Number: 862.1580
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 105 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100263	ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS	May 06, 2011	Substantially Equivalent	Seppim S.A.S.
K072141	S40 CLINICAL ANALYZER, S TEST IP, S TEST UA	Jun 24, 2008	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K041643	SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT	Aug 18, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K030015	ATAC PAK PHOSPHORUS REAGENT	Mar 07, 2003	Substantially Equivalent	Elan Diagnostics
K022312	PICCOLO PHOSPHORUS TEST SYSTEM	Sep 05, 2002	Substantially Equivalent	Abaxis, Inc.
K013095	WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311	Nov 16, 2001	Substantially Equivalent	Wiener Laboratories Saic
K003912	PHOSPHORUS REAGENT	Feb 21, 2001	Substantially Equivalent	Jas Diagnostics, Inc.
K003012	RAICHEM PHOSPORUS REAGENT	Oct 25, 2000	Substantially Equivalent	Hemagen Diagnostics, Inc.
K991867	INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02	Aug 02, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K983503	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347	Dec 01, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K981769	HICHEM PHOSPHORUS REAGENT KIT	Jun 29, 1998	Substantially Equivalent	Elan Pharma, Inc.
K981610	CARESIDE ANALYZER	Jun 25, 1998	Substantially Equivalent	Careside, Inc.
K981759	PHOS	Jun 16, 1998	Substantially Equivalent	Abbott Laboratories
K981118	PHOS	Jun 12, 1998	Substantially Equivalent	Abbott Laboratories
K974858	PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30	Jan 30, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K974605	RANDOX INORGANIC PHOSPHOROUS	Jan 09, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K971363	SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT	Apr 21, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K955937	INORGANIC PHOSPHORUS REAGENT	Mar 12, 1996	Substantially Equivalent	Derma Media Lab., Inc.
K944768	OLYMPUS INORGANIC PHOSPHORUS REAGENT	Mar 24, 1995	Substantially Equivalent	Olympus America, Inc.
K942960	PHOSPHATE QVET	Dec 09, 1994	Substantially Equivalent	Prisma Systems
K945322	PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416	Dec 07, 1994	Substantially Equivalent	Emd Chemicals, Inc.
K945368	PHOSPHORUS TEST (PHOS)	Dec 02, 1994	Substantially Equivalent	Emd Chemicals, Inc.
K935178	EMDS PHOSPHOROUS (PHOS) TEST	Dec 17, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K931835	OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT	Sep 08, 1993	Substantially Equivalent	Olympus Corp.
K932729	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)	Aug 03, 1993	Substantially Equivalent	Eastman Kodak Company
K931361	IL TEST PHOSPHORUS	May 11, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K925057	OLYMPUS INORGANIC PHOSPHORUS REAGENT	Nov 19, 1992	Substantially Equivalent	Olympus Corp.
K924470	TWO PART INORGANIC PHOSPHORUS TEST	Oct 14, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923764	SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000	Sep 22, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923564	OLYMPUS INORGANIC PHOSPHORUS REAGENT	Aug 18, 1992	Substantially Equivalent	Olympus Corp.
K915708	INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET	Jan 22, 1992	Substantially Equivalent	Tech Intl. Co.
K912809	ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14	Aug 12, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K912569	SYNERMED PHOSPHORUS REAGENT KIT	Jul 17, 1991	Substantially Equivalent	Synermed, Inc.
K910296	PHOSPHORUS (INORGANIC) TEST SYSTEM	Feb 27, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K903696	OLYMPUS INORGANIC PHOSPHORUS	Sep 12, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K901964	PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463	May 31, 1990	Substantially Equivalent	American Research Products Co.
K901807	OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)	May 02, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K901137	CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)	Apr 12, 1990	Substantially Equivalent	Technicon Instruments Corp.
K900977	AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500	Apr 11, 1990	Substantially Equivalent	American Research Products Co.
K900215	COULTER PHOSPHORUS REAGENT	Feb 08, 1990	Substantially Equivalent	Coulter Corp.
K895999	PHOSPHORUS	Jan 11, 1990	Substantially Equivalent	American Monitor Corp.
K890773	HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196	Apr 18, 1989	Substantially Equivalent	Hichem Diagnostics
K891218	IQ/QCA PHOSPHORUS	Mar 22, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K885041	BIOTROL INORGANIC PHOSPHORUS	Jan 30, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K884735	PHOSPHORUS TEST (PHOS) ITEM #65666	Dec 16, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K883962	ROCHE REAGENT FOR INORGANIC PHOSPHORUS	Nov 29, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K881171	PHOSPHORUS (INORGANIC)	Apr 28, 1988	Substantially Equivalent	Tech-Co, Inc.
K880676	INORGANIC PHOSPHORUS REAGENT SET	Mar 24, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K874577	KODAK EKTACHEM DT SLIDES (PHOS)	Jan 21, 1988	Substantially Equivalent	Eastman Kodak Company
K874472	INORGANIC PHOSPHORUS	Dec 22, 1987	Substantially Equivalent	Catachem, Inc.
K873454	PARAMAX PHOSPHORUS REAGENT	Nov 23, 1987	Substantially Equivalent	Baxter Healthcare Corp
K874153	EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687	Nov 04, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K874038	MULTICHEM INORGANIC PHOSPHOROUS S0923	Oct 28, 1987	Substantially Equivalent	Simmler, Inc.
K870368	PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION	Aug 19, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K871321	FLOW-PAC INORGANIC PHOSPHORUS REAGENTS	Apr 22, 1987	Substantially Equivalent	American Research Products Co.
K870776	RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT	Mar 13, 1987	Substantially Equivalent	Reagents Applications, Inc.
K863718	EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95	Oct 29, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863088	ABBOTT SPECTRUM PHOSPHORUS REAGENT	Sep 25, 1986	Substantially Equivalent	Abbott Laboratories
K863264	INORGANIC PHOSPHORUS PROCEDURE	Sep 11, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K863072	FOSFOROMETER	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K862834	MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT	Aug 19, 1986	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K861661	INORGANIC PHOSPHORUS PROCEDURE	Jul 01, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861968	AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET	Jun 13, 1986	Substantially Equivalent	American Research Products Co.
K860628	INORGANIC PHOSPHORUS REAGENT SET	Mar 14, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855154	INORGANIC PHOSPHORUS REAGENT SET	Jan 14, 1986	Substantially Equivalent	Technostics Intl.
K854188	IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO	Nov 25, 1985	Substantially Equivalent	Clinical Data, Inc.
K850934	PHOSPHORUS	Jun 25, 1985	Substantially Equivalent	Dilab, Inc.
K852103	INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN	May 31, 1985	Substantially Equivalent	Medical Analysis Systems, Inc.
K852003	IP ACID REAGENT IP MOLY BDATE REAGENT	May 31, 1985	Substantially Equivalent	Alpkem Corp.
K850986	DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE	Apr 01, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K850380	INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER	Mar 01, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K844316	RAICHEM PHOSPHORUS REAGENT	Jan 03, 1985	Substantially Equivalent	Reagents Applications, Inc.
K844182	INORGANIC PHOSPHORUS REAGENT SET	Nov 09, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843330	SYSTEMATE PHOSPHORUS 67217	Sep 14, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K843177	INORGANIC PHOSPHORUS TEST	Sep 14, 1984	Substantially Equivalent	Sclavo, Inc.
K843030	INORGANIC PHOSPHORUS ASSAY KIT	Aug 27, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841181	ASTRA SYS INORGANIC PHOSPHORUS CHEM	May 09, 1984	Substantially Equivalent	Beckman Instruments, Inc.
K841061	PHOPHORUS REAGNET SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K840215	PHOSPHORUS REAGENT SYSTEM	Mar 19, 1984	Substantially Equivalent	Sclavo, Inc.
K833002	PARAMAX PHOSPHORUS REAGENT	Oct 14, 1983	Substantially Equivalent	American Dade
K823691	PHOSPHORUS REAGENT SET	Jan 07, 1983	Substantially Equivalent	Omega Medical Electronics
K823580	COBAS REAGENT FOR INORGANIC PHOSPHORUS	Jan 07, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K822470	PSI INORGANIC PHOSPHORUS	Sep 14, 1982	Substantially Equivalent	Pointe Scientific, Inc.,
K821874	ULTRACHEM PHOS	Jul 13, 1982	Substantially Equivalent	Harleco Diagnostics
K813400	INORGANIC PHOSPHORUS REAGENT SET	Dec 22, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K811749	KING DIAGNOSTICS PHOSPHORUS TEST	Jul 10, 1981	Substantially Equivalent	King Diagnostics, Inc.
K802159	AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS	Oct 10, 1980	Substantially Equivalent	Panmed, Inc.
K800690	REAGENT FOR DETERM. INORGANIC/PHOSPHORUS	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K800297	SANDARE FAST 340 PHOSPHOROUS PROCEDURE	Mar 05, 1980	Substantially Equivalent	Sandare Chemical Co., Inc.
K792401	ELVI INORGANIC PHOSPHOROUS	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K791708	INORGANIC PHOSPHORUS REAGENT	Sep 24, 1979	Substantially Equivalent	Gilford Diagnostics
K790021	SERUM, INORGANIC PHOSPHOROUS	Feb 15, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K781806	REAGENT SYSTEM, INORGANIC PHOSPHORUS	Jan 17, 1979	Substantially Equivalent	Sigma Chemical Co.
K781000	PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS	Dec 04, 1978	Substantially Equivalent	Abbott Laboratories
K772156	ULTRACHEM PHOSPHORUS, 64973	Dec 06, 1977	Substantially Equivalent	Harleco
K771835	INORGANIC PHOSPHORUS	Nov 02, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K771848	PHOSPHORUS TEST KIT	Oct 28, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K771477	MULTISTAT III PHOSPHOROUS TEST	Sep 12, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770820	ULTRACHEM INORGANIC PHOSPHORUS	Jul 11, 1977	Substantially Equivalent	Harleco
K770456	PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT	May 03, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K761239	AUTO-INORGANIC PHOSPHORUS REAGENT	Dec 29, 1976	Substantially Equivalent	Harleco
K761238	AUTO-INORGANIC PHOSPHORUS REAGENT	Dec 29, 1976	Substantially Equivalent	Harleco
K760634	ACA PHOSPHORUS ANALYTICAL TEST PACK	Nov 24, 1976	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K760990	INORGANIC PHOSPHOROUS REAGENT	Nov 16, 1976	Substantially Equivalent	Worthington Biochemical Corp.
K760030	CLINICARD PHOSPHORUS	Sep 13, 1976	Substantially Equivalent	Harleco