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FDA 510(k)

CEDIA VANCOMYCIN ASSAY

K-Number: K032811 · 2003-11-24

ApplicantMicrogenics Corp.
Decision Date2003-11-24
Product CodeLEH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA VANCOMYCIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2003-11-24 under 510(k) number K032811. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA VANCOMYCIN ASSAY?

CEDIA VANCOMYCIN ASSAY is a medical device that received FDA 510(k) clearance on 2003-11-24. The listed applicant is Microgenics Corp.. The 510(k) number is K032811.

When did CEDIA VANCOMYCIN ASSAY receive FDA 510(k) clearance?

CEDIA VANCOMYCIN ASSAY received FDA 510(k) clearance on 2003-11-24, under 510(k) number K032811.

Who is the listed applicant for CEDIA VANCOMYCIN ASSAY?

The FDA 510(k) record lists Microgenics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEDIA VANCOMYCIN ASSAY?

The FDA product code for CEDIA VANCOMYCIN ASSAY is LEH.

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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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