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FDA 510(k)

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

K-Number: K233663 · 2023-12-13

ApplicantSiemens Healthcare Diagnostics Products GmbH
Decision Date2023-12-13
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is a medical device manufactured by Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-12-13 under approval number K233663. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K233663.

When was N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) approved by the FDA?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) received FDA 510(k) clearance on 2023-12-13, under approval number K233663.

What company makes N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is manufactured by Siemens Healthcare Diagnostics Products GmbH.

What is the FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

The FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is CFN.

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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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