FDA product code JQN: Colorimetric, Mucopolysaccharides
JQN is the FDA product code for colorimetric, mucopolysaccharides. It is a Class I device, regulated under 21 CFR 862.1505 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JQN, from 2 different applicants. The average 510(k) review took 34 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric, Mucopolysaccharides |
| Device class | Class I |
| Regulation | 21 CFR 862.1505 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQN clearance
Top JQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J. D. Assoc. | 1 | 1986-09-11 |
| Volu Sol Medical Industries | 1 | 1980-01-16 |
Most recent JQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K863070 | J. D. Assoc. | FAST MUCOPROTEINS | 1986-09-11 | 30 |
| K792554 | Volu Sol Medical Industries | ELVI MUCAPROTEINS | 1980-01-16 | 37 |
Recalls for JQN devices
openFDA lists no recalls for product code JQN.
Frequently asked questions
What is FDA product code JQN?
JQN is the FDA product code for colorimetric, mucopolysaccharides. It is a Class I device, regulated under 21 CFR 862.1505 and reviewed by the Clinical Chemistry panel.
What device class is JQN?
Class I, regulation 21 CFR 862.1505. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQN?
Across 2 cleared submissions the average was 34 days from receipt to decision (median 34).
Which companies have the most JQN clearances?
J. D. Assoc. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQN
- Run a recall and safety report across every JQN manufacturer
- Watch product code JQN 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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