FDA product code JQE: Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
JQE is the FDA product code for resin, ion-exchange, ascorbic acid, colorimetry, iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under JQE, from 6 different applicants. The average 510(k) review took 72 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity |
| Device class | Class I |
| Regulation | 21 CFR 862.1415 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canyon Diagnostics, Inc. | 1 | 1997-02-11 |
| Eastman Kodak Company | 1 | 1994-03-21 |
| J.S. Medical Assoc. | 1 | 1991-04-29 |
| Sclavo, Inc. | 1 | 1988-12-14 |
| Benchmark Reagents | 1 | 1987-02-02 |
1 more applicants have JQE clearances. See the full list in Caduvo.
Most recent JQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970248 | Canyon Diagnostics, Inc. | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM | 1997-02-11 | 20 |
| K934358 | Eastman Kodak Company | KODAK EKTACHEM DT SLIDES (FE) | 1994-03-21 | 194 |
| K910672 | J.S. Medical Assoc. | J&S PEDIATRIC IRON SATURATING REAGENT | 1991-04-29 | 73 |
| K884649 | Sclavo, Inc. | TOTAL IRON BINDING CAPACITY TEST | 1988-12-14 | 37 |
| K864548 | Benchmark Reagents | ALFERR TIBC TUBE | 1987-02-02 | 75 |
Recalls for JQE devices
openFDA lists no recalls for product code JQE.
Frequently asked questions
What is FDA product code JQE?
JQE is the FDA product code for resin, ion-exchange, ascorbic acid, colorimetry, iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel.
What device class is JQE?
Class I, regulation 21 CFR 862.1415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQE?
Across 6 cleared submissions the average was 72 days from receipt to decision (median 55).
Which companies have the most JQE clearances?
Canyon Diagnostics, Inc. (1); Eastman Kodak Company (1); J.S. Medical Assoc. (1); Sclavo, Inc. (1); Benchmark Reagents (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQE
- Run a recall and safety report across every JQE manufacturer
- Watch product code JQE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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