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FDA 510(k)

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)

K-Number: K241800 · 2024-07-26

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2024-07-26
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-07-26 under approval number K241800. 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 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)?

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K241800.

When was Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) approved by the FDA?

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) received FDA 510(k) clearance on 2024-07-26, under approval number K241800.

What company makes Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)?

Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)?

The FDA product code for Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) is MRR.

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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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