Product Code: JIY FDA class 1 21 CFR 862.1410

Photometric Method, Iron (Non-Heme)

Clinical Chemistry

This device is a photometric reagent system used in clinical chemistry laboratories to measure non-heme iron concentrations in serum or other biological specimens, used in the diagnosis and monitoring of iron deficiency anemia, hemochromatosis, and related disorders. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket notification required. The product code is JIY, regulated under 21 CFR 862.1410, and falls within the Clinical Chemistry medical specialty.

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FEI Numbers

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Basic Information

Product Code: JIY
Device Class: FDA class 1
Regulation Number: 862.1410
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 67 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K061793	DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR	Aug 07, 2006	Substantially Equivalent	Dade Behring, Inc.
K060264	DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)	Mar 08, 2006	Substantially Equivalent	Dade Behring, Inc.
K051115	SENTINEL IRON LIQUID	Aug 25, 2005	Substantially Equivalent	Sentinel Ch. Srl
K033983	VITALAB IRON REAGENT	May 21, 2004	Substantially Equivalent	Clinical Data, Inc.
K030528	ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)	Jun 17, 2003	Substantially Equivalent	Clinical Data
K020816	IRON-PC-SL ASSAY MODEL # 151-10, 151-26	May 14, 2002	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K013097	WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003	Nov 13, 2001	Substantially Equivalent	Wiener Laboratories Saic
K981241	IRON	May 01, 1998	Substantially Equivalent	Abbott Laboratories
K973933	SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30	Nov 04, 1997	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K972363	IL TEST IRON	Aug 15, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K964913	IRON REAGENT	Feb 20, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K961588	TOTAL IRON (NITRO-PAPS) REAGENT SET	Nov 18, 1996	Substantially Equivalent	Pointe Scientific, Inc.,
K935712	IRON/TIBC REAGENT	Sep 20, 1995	Substantially Equivalent	Horizon Diagnostics, Inc.
K944911	ACE IRON REAGENT	Feb 10, 1995	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K943029	IRON QVET	Dec 02, 1994	Substantially Equivalent	Prisma Systems
K944462	DMA IRON PROCEDURE	Nov 15, 1994	Substantially Equivalent	Data Medical Associates, Inc.
K935287	IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM	Jan 03, 1994	Substantially Equivalent	Miles, Inc.
K935176	IRON TEST	Dec 16, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K930166	IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R	Apr 21, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924691	OLYMPUS IRON REAGENT	Dec 18, 1992	Substantially Equivalent	Olympus Corp.
K923565	OLYMPUS IRON REAGENT	Sep 28, 1992	Substantially Equivalent	Olympus Corp.
K911170	THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K910143	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)	Feb 04, 1991	Substantially Equivalent	Eastman Kodak Company
K902877	TOTAL IRON FOR MANUAL/AUTOMATED	Jul 27, 1990	Substantially Equivalent	Catachem, Inc.
K902173	COULTER SERUM IRON/UIBC REAGENT	Jun 12, 1990	Substantially Equivalent	Coulter Corp.
K901561	IRON/TOTAL IRON BINDING CAPACITY	May 17, 1990	Substantially Equivalent	Tech-Co, Inc.
K900902	IRON LIQUID STABLE REAGENT	Mar 19, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K895249	SYSTEMATE(TM) IRON ITEM NUMBER: 65417	Oct 31, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K892838	IRON SYSTEM PACK REAGENTS	Jun 16, 1989	Substantially Equivalent	Boehringer Mannheim Corp.
K892863	EASY-TEST IRON (IRON) ITEM NO. 16686	Jun 07, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890573	KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT	Mar 24, 1989	Substantially Equivalent	Kenlor Industries, Inc.
K890395	BIOTROL IRON REAGENT	Mar 08, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K890304	IRON REAGENTS ITEM NUMBER: SR1017	Feb 10, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890034	PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)	Feb 03, 1989	Substantially Equivalent	American Monitor Corp.
K884355	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)	Dec 16, 1988	Substantially Equivalent	Eastman Kodak Company
K883792	TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS	Oct 12, 1988	Substantially Equivalent	Catachem, Inc.
K881202	IRON TEST	Apr 28, 1988	Substantially Equivalent	Sclavo, Inc.
K881167	IRON PROCEDURE	Apr 28, 1988	Substantially Equivalent	Data Medical Associates, Inc.
K881104	PARAMAX IRON REAGENT	Apr 28, 1988	Substantially Equivalent	Baxter Healthcare Corp
K880467	STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR	Mar 24, 1988	Substantially Equivalent	Stanbio Laboratory
K874918	IRON PROCEDURE	Feb 11, 1988	Substantially Equivalent	Data Medical Associates, Inc.
K874263	WAKO(TM) FE C	Nov 23, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K870986	LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT	Apr 13, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K871284	FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339	Apr 08, 1987	Substantially Equivalent	American Research Products Co.
K870144	IRON(IRN) TESTPACK, ITEM NO. 67659/95	Feb 20, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K864819	RAICHEM (TM)SERUM IRON AND TIBC REAGENTS	Feb 12, 1987	Substantially Equivalent	Reagents Applications, Inc.
K864882	FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY	Jan 21, 1987	Substantially Equivalent	Pointe Scientific, Inc.,
K863109	FERROFAST	Nov 24, 1986	Substantially Equivalent	J. D. Assoc.
K863266	IRON PROCEDURE	Sep 11, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861652	IRON PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K860799	ANALYTE IRON/TECHNICON CHEM 1 SYSTEM	Apr 03, 1986	Substantially Equivalent	Technicon Instruments Corp.
K860478	SERUM IRON & IRON BINDING REAGENT SET	Mar 14, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K852161	SERUM IRON/VIBC REAGENT SET	Jun 10, 1985	Substantially Equivalent	Livonia Diagnostics, Inc.
K851394	SANDARE IRON PROCEDURE	Apr 30, 1985	Substantially Equivalent	Sandare Chemical Co., Inc.
K845020	SYSTE MATE IRON, HEM NO. 67224	Jan 28, 1985	Substantially Equivalent	Em Diagnostic Systems, Inc.
K843255	TECHNICON RA-1000 SYS IRON FOR SERUM	Sep 14, 1984	Substantially Equivalent	Technicon Instruments Corp.
K841887	PARAMAX IRON BLANK REAGENT	Jun 22, 1984	Substantially Equivalent	American Dade
K841886	PARAMAX IRON REAGENT	Jun 22, 1984	Substantially Equivalent	American Dade
K833017	SERUM IRON & TIBC#65084 & 65085	Nov 03, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K831201	SERUM IRON-PTF-600	May 25, 1983	Substantially Equivalent	American Monitor Corp.
K821184	SPIN CHEM REAGENTS & STANDARDS	May 24, 1982	Substantially Equivalent	Smithkline Diagnostics, Inc.
K812840	SERUM IRON REAGENT SET	Dec 03, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K812777	DIRECT IRON REAGENT SET	Oct 19, 1981	Substantially Equivalent	The Dow Chemical Co.
K800677	REAGENTS FOR DETERM. SERUM IRON IN HUMAN	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K782160	TOTAL IRON IN SERUM	Jan 26, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K781865	IRON BINDING CAPICITY MODEL 0370	Dec 04, 1978	Substantially Equivalent	Stanbio Laboratory
K771838	SERUM IRON	Nov 03, 1977	Substantially Equivalent	Gamma Enterprises, Inc.