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FDA 510(k)

N LATEX IGM

K-Number: K032014 · 2003-08-07

ApplicantDade Behring, Inc.
Decision Date2003-08-07
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N LATEX 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 2003-08-07 under 510(k) number K032014. 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 LATEX IGM?

N LATEX IGM is a medical device that received FDA 510(k) clearance on 2003-08-07. The listed applicant is Dade Behring, Inc.. The 510(k) number is K032014.

When did N LATEX IGM receive FDA 510(k) clearance?

N LATEX IGM received FDA 510(k) clearance on 2003-08-07, under 510(k) number K032014.

Who is the listed applicant for N LATEX 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 LATEX IGM?

The FDA product code for N LATEX IGM is CFN.

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Related Devices (Code: 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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