MRSA/SA ELITE MGB, ELITE MGB SOFTWARE— 510(k) K132468

Name: FDA 510(k) clearance K132468
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Substantially Equivalent

Elitechgroup Epoch Biosciences

FDA 510(k) clearance K132468 for MRSA/SA ELITE MGB, ELITE MGB SOFTWARE, Substantially Equivalent on 2013-10-17. Applicant: Elitechgroup Epoch Biosciences. Device class: 2.

Clearance details

Applicant: Elitechgroup Epoch Biosciences
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2013-08-07
Decision date: 2013-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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