Product code JMG
- Device name
- Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5340
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234052 | Access Ferritin | Beckman Coulter, Inc. | 2024-03-20 |
| K052082 | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | 2005-08-19 |
| K964282 | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | 1997-07-30 |
| K971833 | ELECSYS FERRITIN | Boehringer Mannheim Corp. | 1997-06-02 |
| K963498 | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | 1997-01-24 |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | 1995-05-16 |
| K926221 | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-13 |
| K925848 | IMMULITE FERRITIN | Diagnostic Products Corp. | 1993-01-13 |
| K920829 | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | 1992-06-19 |
| K920318 | CEDIA FERRITIN ASSAY | Microgenics Corp. | 1992-06-04 |
| K902997 | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | 1990-08-02 |
| K890697 | RIA-GNOST FERRITIN | Cambridge Medical Technology | 1989-03-16 |
| K881138 | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | 1988-04-21 |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1987-11-04 |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | 1987-08-21 |
| K840460 | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | 1984-03-30 |
| K810799 | QUANTIMUNE FERRITIN IRMA | Bio-Rad | 1981-04-03 |
| K792588 | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-01-11 |
| K791096 | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | 1979-08-03 |
| K782157 | IRMA TEST, NORDICLAB FERRITIN | Nordiclab Intl. | 1979-01-17 |
| K781946 | RIA KIT, FERRITIN SOLID PHASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-01-10 |
| K781844 | FERRITIN KIT | Ria Products, Inc. | 1979-01-10 |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | New England Nuclear | 1979-01-10 |
| K781527 | RIA SYSTEM FOR HUMAN FE-RITIN | Calbiochem-Behring Corp. | 1978-10-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590772840 | Access Ferritin | Beckman Coulter, Inc. | 2024-04-05 |
| 00842768013775 | Dimension® Sample Probe Cleaner | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768014277 | Dimension® Chemistry Wash | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768013768 | Dimension® Reagent Probe Cleaner | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768013782 | Dimension® IMT Probe Cleaner | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768000119 | Dimension® Sample Diluent | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00816870020303 | Ferritin AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021997 | Ferritin AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021980 | Ferritin AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020310 | Ferritin AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00842768013928 | Dimension® Reaction Vessels | Siemens Healthcare Diagnostics Inc. | 2018-09-24 |
| 04015630939688 | Elecsys Ferritin | Roche Diagnostics GmbH | 2017-04-21 |
| 00842768013867 | Dimension® Flex® reagent cartridge FERR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414953748 | IMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961460 | IMMULITE® 2000 Systems FER Ferritin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414961477 | IMMULITE® 2000 Systems FER Ferritin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414963976 | IMMULITE®/IMMULITE® 1000 Systems FER Ferritin | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630938957 | Elecsys Ferritin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630938940 | Elecsys Ferritin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630920242 | Elecsys Ferritin CalSet | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590575045 | Access Ferritin Calibrators | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590575052 | Access Ferritin | Beckman Coulter, Inc. | 2016-09-09 |