XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM— 510(k) K130894

Name: FDA 510(k) clearance K130894
Creator: U.S. Food and Drug Administration
Published: 2013-06-20

Substantially Equivalent

Cepheid

FDA 510(k) clearance K130894 for XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM, Substantially Equivalent on 2013-06-20. Applicant: Cepheid. Device class: 2.

Clearance details

Device name as filed: XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE
Applicant: Cepheid
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2013-04-01
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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