HDL-Cholesterol Gen.4
K-Number: K162593 · 2016-10-19
ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-10-19
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
HDL-Cholesterol Gen.4 is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-10-19 under approval number K162593. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HDL-Cholesterol Gen.4?
HDL-Cholesterol Gen.4 is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K162593.
When was HDL-Cholesterol Gen.4 approved by the FDA?
HDL-Cholesterol Gen.4 received FDA 510(k) clearance on 2016-10-19, under approval number K162593.
What company makes HDL-Cholesterol Gen.4?
HDL-Cholesterol Gen.4 is manufactured by Roche Diagnostics Operations (Rdo).
What is the FDA product code for HDL-Cholesterol Gen.4?
The FDA product code for HDL-Cholesterol Gen.4 is LBS.
Other Devices by Roche Diagnostics Operations (Rdo)
Related Devices (Code: LBS)
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.