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FDA 510(k)

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT

K-Number: K040758 · 2004-05-28

ApplicantMicrogenics Corp.
Decision Date2004-05-28
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K040758. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT?

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Microgenics Corp.. The 510(k) number is K040758.

When did MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT receive FDA 510(k) clearance?

MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040758.

Who is the listed applicant for MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT?

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 MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT?

The FDA product code for MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT is DIF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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