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FDA 510(k)

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)

K-Number: K042735 · 2005-02-15

ApplicantDade Behring, Inc.
Decision Date2005-02-15
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 Dade Behring, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K042735. 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 2005-02-15. The listed applicant is Dade Behring, Inc.. The 510(k) number is K042735.

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 2005-02-15, under 510(k) number K042735.

Who is the listed applicant for N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)?

The FDA 510(k) record lists Dade Behring, Inc. 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.

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbHK221114Immunoglobulin 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.

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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