JIY · Photometric Method, Iron (Non-Heme)
Clinical Chemistry · 21 CFR 862.1410 · Class 1
Overview
| Product Code | JIY |
|---|---|
| Device Name | Photometric Method, Iron (Non-Heme) |
| Regulation | 21 CFR 862.1410 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (67)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061793 | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | Aug 7, 2006 | SESE |
| K060264 | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | Dade Behring, Inc. | Mar 8, 2006 | SESE |
| K051115 | SENTINEL IRON LIQUID | Sentinel Ch. Srl | Aug 25, 2005 | SESE |
| K033983 | VITALAB IRON REAGENT | Clinical Data, Inc. | May 21, 2004 | SESE |
| K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | Clinical Data | Jun 17, 2003 | SESE |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | May 14, 2002 | SESE |
| K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | Wiener Laboratories Saic | Nov 13, 2001 | SESE |
| K981241 | IRON | Abbott Laboratories | May 1, 1998 | SESE |
| K973933 | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | Nov 4, 1997 | SESE |
| K972363 | IL TEST IRON | Instrumentation Laboratory CO | Aug 15, 1997 | SESE |
| K964913 | IRON REAGENT | Derma Media Lab., Inc. | Feb 20, 1997 | SESE |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | Nov 18, 1996 | SESE |
| K935712 | IRON/TIBC REAGENT | Horizon Diagnostics, Inc. | Sep 20, 1995 | SESE |
| K944911 | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | Feb 10, 1995 | SESE |
| K943029 | IRON QVET | Prisma Systems | Dec 2, 1994 | SESE |
| K944462 | DMA IRON PROCEDURE | Data Medical Associates, Inc. | Nov 15, 1994 | SESE |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | Miles, Inc. | Jan 3, 1994 | SESE |
| K935176 | IRON TEST | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE |
| K930166 | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | Em Diagnostic Systems, Inc. | Apr 21, 1993 | SESE |
| K924691 | OLYMPUS IRON REAGENT | Olympus Corp. | Dec 18, 1992 | SESE |
| K923565 | OLYMPUS IRON REAGENT | Olympus Corp. | Sep 28, 1992 | SESE |
| K911170 | THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II | Analytical Control Systems, Inc. | May 1, 1991 | SESE |
| K910143 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) | Eastman Kodak Company | Feb 4, 1991 | SESE |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Catachem, Inc. | Jul 27, 1990 | SESE |
| K902173 | COULTER SERUM IRON/UIBC REAGENT | Coulter Corp. | Jun 12, 1990 | SESE |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | Tech-Co, Inc. | May 17, 1990 | SESE |
| K900902 | IRON LIQUID STABLE REAGENT | Medical Analysis Systems, Inc. | Mar 19, 1990 | SESE |
| K895249 | SYSTEMATE(TM) IRON ITEM NUMBER: 65417 | Em Diagnostic Systems, Inc. | Oct 31, 1989 | SESE |
| K892838 | IRON SYSTEM PACK REAGENTS | Boehringer Mannheim Corp. | Jun 16, 1989 | SESE |
| K892863 | EASY-TEST IRON (IRON) ITEM NO. 16686 | Em Diagnostic Systems, Inc. | Jun 7, 1989 | SESE |
| K890573 | KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT | Kenlor Industries, Inc. | Mar 24, 1989 | SESE |
| K890395 | BIOTROL IRON REAGENT | Biotrol, USA, Inc. | Mar 8, 1989 | SESE |
| K890304 | IRON REAGENTS ITEM NUMBER: SR1017 | Em Diagnostic Systems, Inc. | Feb 10, 1989 | SESE |
| K890034 | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) | American Monitor Corp. | Feb 3, 1989 | SESE |
| K884355 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) | Eastman Kodak Company | Dec 16, 1988 | SESE |
| K883792 | TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | Oct 12, 1988 | SESE |
| K881202 | IRON TEST | Sclavo, Inc. | Apr 28, 1988 | SESE |
| K881167 | IRON PROCEDURE | Data Medical Associates, Inc. | Apr 28, 1988 | SESE |
| K881104 | PARAMAX IRON REAGENT | Baxter Healthcare Corp | Apr 28, 1988 | SESE |
| K880467 | STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR | Stanbio Laboratory | Mar 24, 1988 | SESE |
| K874918 | IRON PROCEDURE | Data Medical Associates, Inc. | Feb 11, 1988 | SESE |
| K874263 | WAKO(TM) FE C | Wako Chemicals USA, Inc. | Nov 23, 1987 | SESE |
| K870986 | LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT | Beckman Instruments, Inc. | Apr 13, 1987 | SESE |
| K871284 | FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339 | American Research Products Co. | Apr 8, 1987 | SESE |
| K870144 | IRON(IRN) TESTPACK, ITEM NO. 67659/95 | Em Diagnostic Systems, Inc. | Feb 20, 1987 | SESE |
| K864819 | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS | Reagents Applications, Inc. | Feb 12, 1987 | SESE |
| K864882 | FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY | Pointe Scientific, Inc., | Jan 21, 1987 | SESE |
| K863109 | FERROFAST | J. D. Assoc. | Nov 24, 1986 | SESE |
| K863266 | IRON PROCEDURE | Data Medical Associates, Inc. | Sep 11, 1986 | SESE |
| K861652 | IRON PROCEDURE | Data Medical Associates, Inc. | May 29, 1986 | SESE |
| K860799 | ANALYTE IRON/TECHNICON CHEM 1 SYSTEM | Technicon Instruments Corp. | Apr 3, 1986 | SESE |
| K860478 | SERUM IRON & IRON BINDING REAGENT SET | Sterling Diagnostics, Inc. | Mar 14, 1986 | SESE |
| K852161 | SERUM IRON/VIBC REAGENT SET | Livonia Diagnostics, Inc. | Jun 10, 1985 | SESE |
| K851394 | SANDARE IRON PROCEDURE | Sandare Chemical Co., Inc. | Apr 30, 1985 | SESE |
| K845020 | SYSTE MATE IRON, HEM NO. 67224 | Em Diagnostic Systems, Inc. | Jan 28, 1985 | SESE |
| K843255 | TECHNICON RA-1000 SYS IRON FOR SERUM | Technicon Instruments Corp. | Sep 14, 1984 | SESE |
| K841887 | PARAMAX IRON BLANK REAGENT | American Dade | Jun 22, 1984 | SESE |
| K841886 | PARAMAX IRON REAGENT | American Dade | Jun 22, 1984 | SESE |
| K833017 | SERUM IRON & TIBC#65084 & 65085 | Emd Chemicals, Inc. | Nov 3, 1983 | SESE |
| K831201 | SERUM IRON-PTF-600 | American Monitor Corp. | May 25, 1983 | SESE |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | Smithkline Diagnostics, Inc. | May 24, 1982 | SESE |
| K812840 | SERUM IRON REAGENT SET | Anco Medical Reagents & Assoc. | Dec 3, 1981 | SESE |
| K812777 | DIRECT IRON REAGENT SET | The Dow Chemical Co. | Oct 19, 1981 | SESE |
| K800677 | REAGENTS FOR DETERM. SERUM IRON IN HUMAN | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K782160 | TOTAL IRON IN SERUM | Fisher Scientific Co., LLC | Jan 26, 1979 | SESE |
| K781865 | IRON BINDING CAPICITY MODEL 0370 | Stanbio Laboratory | Dec 4, 1978 | SESE |
| K771838 | SERUM IRON | Gamma Enterprises, Inc. | Nov 3, 1977 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Data Medical Associates, Inc. — 5 clearances
- Technicon Instruments Corp. — 2 clearances
- Stanbio Laboratory — 2 clearances
- Pointe Scientific, Inc., — 2 clearances
