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FDA 510(k)

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE

K-Number: K132468 · 2013-10-17

ApplicantElitechgroup Epoch Biosciences
Decision Date2013-10-17
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup Epoch Biosciences. It received FDA 510(k) clearance on 2013-10-17 under 510(k) number K132468. 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, ELITE MGB SOFTWARE?

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-10-17. The listed applicant is Elitechgroup Epoch Biosciences. The 510(k) number is K132468.

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

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE received FDA 510(k) clearance on 2013-10-17, under 510(k) number K132468.

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

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

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

The FDA product code for MRSA/SA ELITE MGB, ELITE MGB SOFTWARE 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.

K243625Xpert MRSA/SA SSTICepheid®K243070Xpert® SA Nasal CompleteCepheid®K191742ARIES MRSA AssayLuminex CorporationK190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheidK162444Xpert MRSA NxGCepheidK133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.

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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