Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
The Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity test is a clinical chemistry diagnostic device used to measure total iron binding capacity (TIBC) using ion-exchange resin separation combined with ascorbic acid reduction and colorimetric quantification of iron, supporting the investigation of iron deficiency and iron overload states. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQE and is regulated under 21 CFR 862.1415, within the Clinical Chemistry medical specialty.
Research product code JQE in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JQE
- Device Class
- FDA class 1
- Regulation Number
- 862.1415
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970248 | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM | Feb 11, 1997 | Substantially Equivalent | Canyon Diagnostics, Inc. |
| K934358 | KODAK EKTACHEM DT SLIDES (FE) | Mar 21, 1994 | Substantially Equivalent | Eastman Kodak Company |
| K910672 | J&S PEDIATRIC IRON SATURATING REAGENT | Apr 29, 1991 | Substantially Equivalent | J.S. Medical Assoc. |
| K884649 | TOTAL IRON BINDING CAPACITY TEST | Dec 14, 1988 | Substantially Equivalent | Sclavo, Inc. |
| K864548 | ALFERR TIBC TUBE | Feb 02, 1987 | Substantially Equivalent | Benchmark Reagents |
| K842019 | TIBC PRETREATMENT KIT | Jun 22, 1984 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.