Radiometric, Fe59, Iron Binding Capacity
The Radiometric, Fe59, Iron Binding Capacity test is a clinical chemistry diagnostic device that uses radioactive iron-59 (Fe59) as a tracer to measure iron binding capacity in serum by radiometric techniques, supporting evaluation of iron metabolism and related hematological conditions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQG and is regulated under 21 CFR 862.1415, within the Clinical Chemistry medical specialty.
Research product code JQG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JQG
- Device Class
- FDA class 1
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K811954 | COMBO-FER IRON DIAGNOSTIC | Jul 27, 1981 | Substantially Equivalent | Immuno Assay Corp. |
| K800710 | FERRITIRON KIT CAT. #RP-1100 | May 14, 1980 | Substantially Equivalent | Ria Products, Inc. |
| K800868 | FERRO-QUANT TM FE 59 TEST KIT | Apr 29, 1980 | Substantially Equivalent | Mallinckrodt Critical Care |
| K790133 | SPINSEP-FE59 | Mar 02, 1979 | Substantially Equivalent | Nuclear Diagnostics, Inc. |
| K780412 | TOTAL IRON BINDING CAPACITY | May 26, 1978 | Substantially Equivalent | Diagnostic Corp. of America |