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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-10-19 under 510(k) 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. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K162593.

When did HDL-Cholesterol Gen.4 receive FDA 510(k) clearance?

HDL-Cholesterol Gen.4 received FDA 510(k) clearance on 2016-10-19, under 510(k) number K162593.

Who is the listed applicant for HDL-Cholesterol Gen.4?

The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL-Cholesterol Gen.4?

The FDA product code for HDL-Cholesterol Gen.4 is LBS.

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Related Devices (Code: LBS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.

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.

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