Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
This device is a clinical chemistry reagent system that measures osmolality of serum and urine by comparing the freezing point depression of patient specimens against standards of known osmotic pressure, used in assessment of fluid and electrolyte balance, renal concentrating ability, and diagnosis of diabetes insipidus or SIADH. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMZ, regulated under 21 CFR 862.1540, and assigned to the Clinical Chemistry medical specialty.
Basic Information
- Product Code
- JMZ
- Device Class
- FDA class 1
- Regulation Number
- 862.1540
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.