← FDA Medical Device Classifications
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
PYP · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1475
Classification
- FDA Product Code
PYP- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.1475
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown