Ninhydrin, Nitrogen (Amino-Nitrogen)
This device is a clinical chemistry reagent system using ninhydrin to measure amino-nitrogen concentrations in patient specimens, used in nutritional assessment and evaluation of amino acid metabolism disorders where abnormal levels of free amino acids are present in biological fluids. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMX, regulated under 21 CFR 862.1515, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JMX
- Device Class
- FDA class 1
- Regulation Number
- 862.1515
- 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 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.