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.
Recent Cleared Devices (20 of 67)
Showing 20 most recent of 67 cleared devices.
| 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 |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Data Medical Associates, Inc. — 5 clearances
- American Dade — 2 clearances
- American Monitor Corp. — 2 clearances
- Catachem, Inc. — 2 clearances
