JQE · Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Clinical Chemistry · 21 CFR 862.1415 · Class 1
Overview
| Product Code | JQE |
|---|---|
| Device Name | Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, 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 (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970248 | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM | Canyon Diagnostics, Inc. | Feb 11, 1997 | SESE |
| K934358 | KODAK EKTACHEM DT SLIDES (FE) | Eastman Kodak Company | Mar 21, 1994 | SESE |
| K910672 | J&S PEDIATRIC IRON SATURATING REAGENT | J.S. Medical Assoc. | Apr 29, 1991 | SESE |
| K884649 | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | Dec 14, 1988 | SESE |
| K864548 | ALFERR TIBC TUBE | Benchmark Reagents | Feb 2, 1987 | SESE |
| K842019 | TIBC PRETREATMENT KIT | E.I. Dupont DE Nemours & Co., Inc. | Jun 22, 1984 | SESE |
Top Applicants
- Sclavo, Inc. — 1 clearance
- J.S. Medical Assoc. — 1 clearance
- Eastman Kodak Company — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Canyon Diagnostics, Inc. — 1 clearance
