JQG · Radiometric, Fe59, Iron Binding Capacity
Clinical Chemistry · 21 CFR 862.1415 · Class 1
Overview
| Product Code | JQG |
|---|---|
| Device Name | Radiometric, Fe59, Iron Binding Capacity |
| Regulation | 21 CFR 862.1415 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811954 | COMBO-FER IRON DIAGNOSTIC | Immuno Assay Corp. | Jul 27, 1981 | SESE |
| K800710 | FERRITIRON KIT CAT. #RP-1100 | Ria Products, Inc. | May 14, 1980 | SESE |
| K800868 | FERRO-QUANT TM FE 59 TEST KIT | Mallinckrodt Critical Care | Apr 29, 1980 | SESE |
| K790133 | SPINSEP-FE59 | Nuclear Diagnostics, Inc. | Mar 2, 1979 | SESE |
| K780412 | TOTAL IRON BINDING CAPACITY | Diagnostic Corp. of America | May 26, 1978 | SESE |
Top Applicants
- Ria Products, Inc. — 1 clearance
- Nuclear Diagnostics, Inc. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Immuno Assay Corp. — 1 clearance
- Diagnostic Corp. of America — 1 clearance
