FDA product code JQG: Radiometric, Fe59, Iron Binding Capacity
JQG is the FDA product code for radiometric, fe59, 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 5 510(k) submissions under JQG, from 5 different applicants. The average 510(k) review took 37 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Radiometric, Fe59, 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 |
Compare with all 510(k) review times · Search every JQG clearance
Top JQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno Assay Corp. | 1 | 1981-07-27 |
| Ria Products, Inc. | 1 | 1980-05-14 |
| Mallinckrodt Critical Care | 1 | 1980-04-29 |
| Nuclear Diagnostics, Inc. | 1 | 1979-03-02 |
| Diagnostic Corp. of America | 1 | 1978-05-26 |
Most recent JQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811954 | Immuno Assay Corp. | COMBO-FER IRON DIAGNOSTIC | 1981-07-27 | 19 |
| K800710 | Ria Products, Inc. | FERRITIRON KIT CAT. #RP-1100 | 1980-05-14 | 44 |
| K800868 | Mallinckrodt Critical Care | FERRO-QUANT TM FE 59 TEST KIT | 1980-04-29 | 12 |
| K790133 | Nuclear Diagnostics, Inc. | SPINSEP-FE59 | 1979-03-02 | 38 |
| K780412 | Diagnostic Corp. of America | TOTAL IRON BINDING CAPACITY | 1978-05-26 | 72 |
Recalls for JQG devices
openFDA lists no recalls for product code JQG.
Frequently asked questions
What is FDA product code JQG?
JQG is the FDA product code for radiometric, fe59, 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 JQG?
Class I, regulation 21 CFR 862.1415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQG?
Across 5 cleared submissions the average was 37 days from receipt to decision (median 38).
Which companies have the most JQG clearances?
Immuno Assay Corp. (1); Ria Products, Inc. (1); Mallinckrodt Critical Care (1); Nuclear Diagnostics, Inc. (1); Diagnostic Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQG
- Run a recall and safety report across every JQG manufacturer
- Watch product code JQG 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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