FDA 510(k)

AXINON® LDL-p Test System

K-Number: K210801 · 2023-07-19

Decision Date2023-07-19

Product CodeMRR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AXINON® LDL-p Test System is the device name listed in this FDA 510(k) record. The listed applicant is Numares AG. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K210801. 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 AXINON® LDL-p Test System?

AXINON® LDL-p Test System is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Numares AG. The 510(k) number is K210801.

When did AXINON® LDL-p Test System receive FDA 510(k) clearance?

AXINON® LDL-p Test System received FDA 510(k) clearance on 2023-07-19, under 510(k) number K210801.

Who is the listed applicant for AXINON® LDL-p Test System?

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

What is the FDA product code for AXINON® LDL-p Test System?

The FDA product code for AXINON® LDL-p Test System is MRR.

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.K161691Direct LDL Cholesterol (LDL)Randox Laboratories Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.