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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-12-13 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K233663.

When did N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) receive FDA 510(k) clearance?

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

Who is the listed applicant for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: CFN)

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.

K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.K190686Optilite IgM CSF KitThe Binding Site Group , Ltd.

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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