Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Direct HDL Cholesterol (HDL)

K-Number: K153435 · 2016-01-08

ApplicantRandox Laboratories, Ltd.
Decision Date2016-01-08
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Direct HDL Cholesterol (HDL) is a medical device manufactured by Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2016-01-08 under approval number K153435. 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 Direct HDL Cholesterol (HDL)?

Direct HDL Cholesterol (HDL) is a medical device that received FDA 510(k) clearance on 2016-01-08. It is manufactured by Randox Laboratories, Ltd.. The 510(k) number is K153435.

When was Direct HDL Cholesterol (HDL) approved by the FDA?

Direct HDL Cholesterol (HDL) received FDA 510(k) clearance on 2016-01-08, under approval number K153435.

What company makes Direct HDL Cholesterol (HDL)?

Direct HDL Cholesterol (HDL) is manufactured by Randox Laboratories, Ltd..

What is the FDA product code for Direct HDL Cholesterol (HDL)?

The FDA product code for Direct HDL Cholesterol (HDL) is LBS.

Other Devices by Randox Laboratories, Ltd.

K152085Liquid CO2-2 (LCO2-2) K162200Randox RX Daytona Plus Magnesium (MG) K182042Randox Calcium (Ca) K230890ISE Electrodes DEN240035ConcizuTrace™ ELISA

Related Devices (Code: LBS)

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)

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.

↑