Direct LDL Cholesterol (LDL)— 510(k) K161691
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K161691 for Direct LDL Cholesterol (LDL), Substantially Equivalent on 2017-03-20. Applicant: Randox Laboratories Limited. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories Limited
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
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More clearances from Randox Laboratories Limited
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