FDA product code JQZ: Polarimeter
JQZ is the FDA product code for polarimeter. 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 JQZ. The average 510(k) review took 23 days (median 23).
Classification
| Field | Value |
|---|---|
| Device name | Polarimeter |
| 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 JQZ clearance
Top JQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 1 | 1981-05-29 |
Most recent JQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811263 | Abbott Laboratories | TOX TM ANALYZER | 1981-05-29 | 23 |
Recalls for JQZ devices
openFDA lists no recalls for product code JQZ.
Frequently asked questions
What is FDA product code JQZ?
JQZ is the FDA product code for polarimeter. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JQZ?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQZ?
Across 1 cleared submissions the average was 23 days from receipt to decision (median 23).
Which companies have the most JQZ clearances?
Abbott Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQZ
- Run a recall and safety report across every JQZ manufacturer
- Watch product code JQZ 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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