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FDA 510(k)

AXINON® LDL-p Test System

K-Number: K210801 · 2023-07-19

ApplicantNumares AG
Decision Date2023-07-19
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXINON® LDL-p Test System is a medical device manufactured by Numares AG. It received FDA 510(k) clearance on 2023-07-19 under approval 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. It is manufactured by Numares AG. The 510(k) number is K210801.

When was AXINON® LDL-p Test System approved by the FDA?

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

What company makes AXINON® LDL-p Test System?

AXINON® LDL-p Test System is manufactured by Numares AG.

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)

K161691Direct LDL Cholesterol (LDL)Randox Laboratories Limited K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.

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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