NFX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Cholesterol, Total, Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR (K033899) | Lifestream Technologies, Inc. | 2004-05-20 | + Add |
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Every clearance here is in the API, with alerts when new ones post.