DIRECT LDL/HDL CHOLESTEROL CALIBRATOR— 510(k) K122126
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K122126 for DIRECT LDL/HDL CHOLESTEROL CALIBRATOR, Substantially Equivalent on 2012-08-14. Applicant: Randox Laboratories Limited. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories Limited
- Product code
- Code JIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, County Antrim, GA
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More clearances from Randox Laboratories Limited
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