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FDA 510(k)

MRSA/SA ELITE MGB

K-Number: K112937 · 2012-06-01

ApplicantElitech
Decision Date2012-06-01
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSA/SA ELITE MGB is the device name listed in this FDA 510(k) record. The listed applicant is Elitech. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K112937. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRSA/SA ELITE MGB?

MRSA/SA ELITE MGB is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Elitech. The 510(k) number is K112937.

When did MRSA/SA ELITE MGB receive FDA 510(k) clearance?

MRSA/SA ELITE MGB received FDA 510(k) clearance on 2012-06-01, under 510(k) number K112937.

Who is the listed applicant for MRSA/SA ELITE MGB?

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

What is the FDA product code for MRSA/SA ELITE MGB?

The FDA product code for MRSA/SA ELITE MGB is NQX.

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Related Devices (Code: NQX)

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.

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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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