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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2017-03-20 under 510(k) 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. The listed applicant is Randox Laboratories Limited. The 510(k) number is K161691.

When did Direct LDL Cholesterol (LDL) receive FDA 510(k) clearance?

Direct LDL Cholesterol (LDL) received FDA 510(k) clearance on 2017-03-20, under 510(k) number K161691.

Who is the listed applicant for Direct LDL Cholesterol (LDL)?

The FDA 510(k) record lists Randox Laboratories Limited as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Direct LDL Cholesterol (LDL) is MRR.

Other records listing Randox Laboratories Limited as applicant

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.

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AG

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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