FDA product code JJP: Electrode, Ion Selective (Non-Specified)
JJP is the FDA product code for electrode, ion selective (non-specified). It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under JJP, from 3 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Selective (Non-Specified) |
| 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 JJP clearance
Top JJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amicon, Inc. | 1 | 1990-02-16 |
| Nova Biomedical Corp. | 1 | 1986-09-29 |
| Reagent Laboratory, Inc. | 1 | 1986-02-10 |
Most recent JJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900280 | Amicon, Inc. | CENTRIPREP 100 | 1990-02-16 | 29 |
| K863438 | Nova Biomedical Corp. | NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER | 1986-09-29 | 24 |
| K860143 | Reagent Laboratory, Inc. | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | 1986-02-10 | 26 |
Recalls for JJP devices
openFDA lists no recalls for product code JJP.
Frequently asked questions
What is FDA product code JJP?
JJP is the FDA product code for electrode, ion selective (non-specified). It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JJP?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJP?
Across 3 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most JJP clearances?
Amicon, Inc. (1); Nova Biomedical Corp. (1); Reagent Laboratory, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJP
- Run a recall and safety report across every JJP manufacturer
- Watch product code JJP 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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