FDA product code JQQ: Dialyzer
JQQ is the FDA product code for dialyzer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JQQ. The average 510(k) review took 13 days (median 13).
Classification
| Field | Value |
|---|---|
| Device name | Dialyzer |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JQQ clearance
Top JQQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amicon, Inc. | 1 | 1976-12-06 |
Most recent JQQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K761100 | Amicon, Inc. | MULTI-CELL ULTRAFILTRATION SYSTEM | 1976-12-06 | 13 |
Recalls for JQQ devices
openFDA lists no recalls for product code JQQ.
Frequently asked questions
What is FDA product code JQQ?
JQQ is the FDA product code for dialyzer. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JQQ?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQQ?
Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).
Which companies have the most JQQ clearances?
Amicon, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQQ
- Run a recall and safety report across every JQQ manufacturer
- Watch product code JQQ 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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