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

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.

Clearance details

Applicant: Cepheid
Product code: Code NQX
Advisory panel: Microbiology
Date received: 2010-07-06
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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