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510(k) K132468

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE by Elitechgroup Epoch Biosciences — Product Code NQX

K132468 is an FDA 510(k) premarket notification submitted by Elitechgroup Epoch Biosciences for the device "MRSA/SA ELITE MGB, ELITE MGB SOFTWARE". The FDA issued a decision of Substantially Equivalent on October 17, 2013. The device falls under product code NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen), a Class II device regulated under 21 CFR 866.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
August 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

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FDA data resources