Radio-Labeled Iron Method, Iron (Non-Heme)
This device is a radio-labeled iron method system used in clinical chemistry to measure non-heme iron in biological samples by incorporating a radioactive tracer, enabling highly sensitive quantification relevant to diagnosing iron metabolism disorders. It is classified as FDA Class 1, indicating low risk and subjecting the device only to general regulatory controls without a premarket notification requirement. The product code is JJA, regulated under 21 CFR 862.1410, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJA
- Device Class
- FDA class 1
- Regulation Number
- 862.1410
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K820253 | SIMUL-FER SERUM IRON TEST KIT | May 12, 1982 | Substantially Equivalent | Diagnostic Reagents, Inc. |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | Feb 01, 1979 | Substantially Equivalent | Leeco Diagnostics, Inc. |
| K781769 | IRON 59 KIT | Dec 04, 1978 | Substantially Equivalent | Ria Products, Inc. |
| K760045 | KIT, RADIOASSAY, SERUM IRON | Jul 20, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |