Electrode, Ion Selective (Non-Specified)
This device is a non-specified ion-selective electrode used in clinical chemistry analyzers to measure the concentration of specific ions in patient specimens, serving as a component within broader analytical systems for electrolyte and metabolite testing. It is classified as FDA Class 1 and is exempt from Good Manufacturing Practice (GMP) requirements, reflecting its low regulatory burden. The product code is JJP, regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJP
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K900280 | CENTRIPREP 100 | Feb 16, 1990 | Substantially Equivalent | Amicon, Inc. |
| K863438 | NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER | Sep 29, 1986 | Substantially Equivalent | Nova Biomedical Corp. |
| K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | Feb 10, 1986 | Substantially Equivalent | Reagent Laboratory, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.