JQEClass I
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
21 CFR 862.1415 / Clinical Chemistry
JQE is the FDA product code for Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity, a class I device type, regulated under 21 CFR 862.1415. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JQE
- Device name
- Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
- Regulation
- 21 CFR 862.1415
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code JQE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1991 | 1 |
| 1994 | 1 |
| 1997 | 1 |
Applicants with the most clearances
Product code JQE| Applicant | Clearances |
|---|---|
| Benchmark Reagents | 1 |
| Canyon Diagnostics, Inc. | 1 |
| E.I. Dupont de Nemours & Co., Inc. | 1 |
| Eastman Kodak Company | 1 |
| J.S. Medical Assoc. | 1 |
| Sclavo, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
