Hexane Extraction, Fluorescence, Vitamin E
The Hexane Extraction, Fluorescence, Vitamin E test is a clinical chemistry diagnostic device used to measure vitamin E (tocopherol) in serum or plasma by hexane extraction followed by fluorometric detection. Vitamin E testing supports evaluation of nutritional status and antioxidant deficiency, particularly in premature infants and individuals with malabsorption disorders. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JOB and is regulated under 21 CFR 862.1815, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JOB
- Device Class
- FDA class 1
- Regulation Number
- 862.1815
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932852 | NON INVASIVE VASCULAR PROGRAM | Feb 04, 1994 | Substantially Equivalent | D. E. Hokanson, Inc. |
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.