FDA product code JSZ: Kit, Identification, Pseudomonas
JSZ is the FDA product code for kit, identification, pseudomonas. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under JSZ. The average 510(k) review took 25 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Identification, Pseudomonas |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JSZ clearance
Top JSZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Austin Biological Laboratories | 1 | 1983-06-17 |
Most recent JSZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831655 | Austin Biological Laboratories | SPECTRUM-10 | 1983-06-17 | 25 |
Recalls for JSZ devices
openFDA lists no recalls for product code JSZ.
Frequently asked questions
What is FDA product code JSZ?
JSZ is the FDA product code for kit, identification, pseudomonas. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JSZ?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JSZ?
Across 1 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most JSZ clearances?
Austin Biological Laboratories (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JSZ
- Run a recall and safety report across every JSZ manufacturer
- Watch product code JSZ 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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