FDA product code JQJ: Densitometeric, Protein Fractionation
JQJ is the FDA product code for densitometeric, 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 JQJ. The average 510(k) review took 76 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Densitometeric, 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 |
Compare with all 510(k) review times · Search every JQJ clearance
Top JQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 1 | 1990-06-12 |
Most recent JQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901463 | Helena Laboratories | REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) | 1990-06-12 | 76 |
Recalls for JQJ devices
openFDA lists no recalls for product code JQJ.
Frequently asked questions
What is FDA product code JQJ?
JQJ is the FDA product code for densitometeric, 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 JQJ?
Class I, regulation 21 CFR 862.1630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQJ?
Across 1 cleared submissions the average was 76 days from receipt to decision (median 76).
Which companies have the most JQJ clearances?
Helena Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQJ
- Run a recall and safety report across every JQJ manufacturer
- Watch product code JQJ 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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