Direct LDL Cholesterol (LDL)
K-Number: K161691 · 2017-03-20
ApplicantRandox Laboratories Limited
Decision Date2017-03-20
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Direct LDL Cholesterol (LDL) is a medical device manufactured by Randox Laboratories Limited. It received FDA 510(k) clearance on 2017-03-20 under approval number K161691. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Direct LDL Cholesterol (LDL)?
Direct LDL Cholesterol (LDL) is a medical device that received FDA 510(k) clearance on 2017-03-20. It is manufactured by Randox Laboratories Limited. The 510(k) number is K161691.
When was Direct LDL Cholesterol (LDL) approved by the FDA?
Direct LDL Cholesterol (LDL) received FDA 510(k) clearance on 2017-03-20, under approval number K161691.
What company makes Direct LDL Cholesterol (LDL)?
Direct LDL Cholesterol (LDL) is manufactured by Randox Laboratories Limited.
What is the FDA product code for Direct LDL Cholesterol (LDL)?
The FDA product code for Direct LDL Cholesterol (LDL) is MRR.
Other Devices by Randox Laboratories Limited
Related Devices (Code: MRR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.