XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10— 510(k) K101879

Name: FDA 510(k) clearance K101879
Creator: U.S. Food and Drug Administration
Published: 2010-07-28

Substantially Equivalent

Cepheid

FDA 510(k) clearance K101879 for XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10, Substantially Equivalent on 2010-07-28. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2010-07-06
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.