Electrophoretic Method, Catecholamines
The Electrophoretic Method, Catecholamines test system (product code CHT) is an in-vitro diagnostic device used in clinical chemistry to measure and separate catecholamines such as epinephrine, norepinephrine, and dopamine in biological specimens using electrophoretic separation, supporting the diagnosis of adrenal and neural crest tumors. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1165 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CHT
- Device Class
- FDA class 1
- Regulation Number
- 862.1165
- 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 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.