FDA product code JQK: Immunodiffusion, Protein Fractionation
JQK is the FDA product code for immunodiffusion, protein fractionation. It is a Class I device, regulated under 21 CFR 862.1630 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JQK. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Immunodiffusion, Protein Fractionation |
| Device class | Class I |
| Regulation | 21 CFR 862.1630 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JQK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electrophoresis Corp. of America | 1 | 1978-12-20 |
Most recent JQK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781898 | Electrophoresis Corp. of America | CLEARING SOLUTION #ECA01976 | 1978-12-20 | 37 |
Recalls for JQK devices
openFDA lists no recalls for product code JQK.
Frequently asked questions
What is FDA product code JQK?
JQK is the FDA product code for immunodiffusion, protein fractionation. It is a Class I device, regulated under 21 CFR 862.1630 and reviewed by the Clinical Chemistry panel.
What device class is JQK?
Class I, regulation 21 CFR 862.1630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQK?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most JQK clearances?
Electrophoresis Corp. of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQK
- Run a recall and safety report across every JQK manufacturer
- Watch product code JQK 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.
All Clinical Chemistry product codes · FDA product code lookup