Membrane Osmometry, Plasma Oncometry
The Membrane Osmometry, Plasma Oncometry device is a clinical chemistry instrument used to measure the colloid osmotic pressure (oncotic pressure) of plasma or other biological fluids using membrane osmometry. Colloid osmotic pressure measurements are used to assess fluid balance and guide fluid management in clinical care settings. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JNX and is regulated under 21 CFR 862.1530, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JNX
- Device Class
- FDA class 1
- Regulation Number
- 862.1530
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.