Direct HDL Cholesterol (HDL)— 510(k) K153435
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K153435 for Direct HDL Cholesterol (HDL), Substantially Equivalent on 2016-01-08. Applicant: Randox Laboratories, Ltd..
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code LBS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.