JJA · Radio-Labeled Iron Method, Iron (Non-Heme)
Clinical Chemistry · 21 CFR 862.1410 · Class 1
Overview
| Product Code | JJA |
|---|---|
| Device Name | Radio-Labeled Iron 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820253 | SIMUL-FER SERUM IRON TEST KIT | Diagnostic Reagents, Inc. | May 12, 1982 | SESE |
| K782159 | DIAGNOSTIC KIT, FERRITAB-FE-59 | Leeco Diagnostics, Inc. | Feb 1, 1979 | SESE |
| K781769 | IRON 59 KIT | Ria Products, Inc. | Dec 4, 1978 | SESE |
| K760045 | KIT, RADIOASSAY, SERUM IRON | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 20, 1976 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Diagnostic Reagents, Inc. — 1 clearance
- Leeco Diagnostics, Inc. — 1 clearance
- Ria Products, Inc. — 1 clearance
