Test, Cholesterol, Total, Over The Counter
The Test, Cholesterol, Total, Over The Counter (product code NFX) is an in vitro diagnostic test for consumer home use that measures total cholesterol levels in blood, enabling individuals to monitor cardiovascular risk without a laboratory visit. It is classified as an FDA Class 1 device within the Clinical Chemistry specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NFX
- Device Class
- FDA class 1
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K033899 | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR | May 20, 2004 | Substantially Equivalent | Lifestream Technologies, Inc. |
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.