Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
FDA product code JQE · Class I (low risk) · 21 CFR 862.1415 · Clinical Chemistry
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970248 | Cantrol Serum Iron and Total Iron Binding Capacity Test SystemJQE · Traditional | Canyon Diagnostics, Inc. | 02/11/1997SE |
| K934358 | Kodak Ektachem DT Slides (Fe)JQE · Traditional | Eastman Kodak Company | 03/21/1994SE |
| K910672 | J&S Pediatric Iron Saturating ReagentJQE · Traditional | J.S. Medical Assoc. | 04/29/1991SE |
| K884649 | Total Iron Binding Capacity TestJQE · Traditional | Sclavo, Inc. | 12/14/1988SE |
| K864548 | Alferr Tibc TubeJQE · Traditional | Benchmark Reagents | 02/02/1987SE |
| K842019 | Tibc Pretreatment KitJQE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/22/1984SE |