Product code JIY
- Device name
- Photometric Method, Iron (Non-Heme)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1410
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061793 | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-08-07 |
| K060264 | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | Dade Behring, Inc. | 2006-03-08 |
| K051115 | SENTINEL IRON LIQUID | Sentinel Ch. Srl | 2005-08-25 |
| K033983 | VITALAB IRON REAGENT | Clinical Data, Inc. | 2004-05-21 |
| K030528 | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | Clinical Data | 2003-06-17 |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | 2002-05-14 |
| K013097 | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | Wiener Laboratories Saic | 2001-11-13 |
| K981241 | IRON | Abbott Laboratories | 1998-05-01 |
| K973933 | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| K972363 | IL TEST IRON | Instrumentation Laboratory CO | 1997-08-15 |
| K964913 | IRON REAGENT | Derma Media Lab., Inc. | 1997-02-20 |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | 1996-11-18 |
| K935712 | IRON/TIBC REAGENT | Horizon Diagnostics, Inc. | 1995-09-20 |
| K944911 | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | 1995-02-10 |
| K943029 | IRON QVET | Prisma Systems | 1994-12-02 |
| K944462 | DMA IRON PROCEDURE | Data Medical Associates, Inc. | 1994-11-15 |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | Miles, Inc. | 1994-01-03 |
| K935176 | IRON TEST | Em Diagnostic Systems, Inc. | 1993-12-16 |
| K930166 | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | Em Diagnostic Systems, Inc. | 1993-04-21 |
| K924691 | OLYMPUS IRON REAGENT | Olympus Corp. | 1992-12-18 |
| K923565 | OLYMPUS IRON REAGENT | Olympus Corp. | 1992-09-28 |
| K911170 | THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II | Analytical Control Systems, Inc. | 1991-05-01 |
| K910143 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) | Eastman Kodak Company | 1991-02-04 |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Catachem, Inc. | 1990-07-27 |
| K902173 | COULTER SERUM IRON/UIBC REAGENT | Coulter Corp. | 1990-06-12 |
| K901561 | IRON/TOTAL IRON BINDING CAPACITY | Tech-Co, Inc. | 1990-05-17 |
| K900902 | IRON LIQUID STABLE REAGENT | Medical Analysis Systems, Inc. | 1990-03-19 |
| K895249 | SYSTEMATE(TM) IRON ITEM NUMBER: 65417 | Em Diagnostic Systems, Inc. | 1989-10-31 |
| K892838 | IRON SYSTEM PACK REAGENTS | Boehringer Mannheim Corp. | 1989-06-16 |
| K892863 | EASY-TEST IRON (IRON) ITEM NO. 16686 | Em Diagnostic Systems, Inc. | 1989-06-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336226803 | IRON Gen.2 | Roche Diagnostics GmbH | 2025-01-14 |
| 10673486002003 | Teco Diagnostics Iron Reagent Kit for TC Matrix | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486001983 | Teco Diagnostics Iron/TIBC Reagent Set | TECO DIAGNOSTICS | 2023-11-13 |
| 00380740160692 | ARCHITECT | ABBOTT IRELAND | 2023-10-20 |
| 00380740160708 | ARCHITECT | ABBOTT IRELAND | 2023-10-20 |
| 00380740168285 | Alinity | ABBOTT IRELAND | 2023-10-20 |
| 00630414610849 | Atellica CH Iron3 (Iron3) | Siemens Healthcare Diagnostics Inc. | 2023-05-10 |
| 00630414305011 | Atellica CH Iron3 (Iron3) | Siemens Healthcare Diagnostics Inc. | 2023-05-10 |
| 00817302024128 | CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024333 | CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT CC618 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024463 | CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT DT618 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024609 | CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT ST618 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 04015630926947 | Iron Gen.2 | Roche Diagnostics GmbH | 2021-06-11 |
| 00811727016188 | Pointe Iron Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 04015630918904 | Iron Gen.2 | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630921119 | Unsaturated Iron-Binding Capacity | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630925049 | Iron Gen.2 | Roche Diagnostics GmbH | 2021-01-18 |
| 04015630928088 | Unsaturated Iron-Binding Capacity | Roche Diagnostics GmbH | 2021-01-18 |
| 00630414513157 | ADVIA® Chemistry IRON_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414561974 | ADVIA® Chemistry IRON_2 Iron 2 Reagents | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414596402 | Atellica CH Iron_2 | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768015236 | Dimension Vista® Flex® reagent cartridge IRON | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768020414 | Dimension® Flex® reagent cartridge IRON | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 03610230007051 | Yumizen C1200 Iron | HORIBA ABX SAS | 2020-07-13 |
| 00811727015884 | Pointe Total Iron for the BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 10758750000289 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 10758750009244 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336121344 | Iron Gen.2 | Roche Diagnostics GmbH | 2020-03-05 |
| 15099590010812 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 03610230005002 | ABX PENTRA IRON CP | HORIBA ABX SAS | 2016-08-23 |