XPERT C. DIFFICLE/EPI ASSAY— 510(k) K110203

Clearance details

Applicant

Cepheid

Product code

Code OMN

Device class

Class 1

Regulation

21 CFR 866.2660

Advisory panel

Microbiology

Date received

2011-01-24

Decision date

2011-04-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sunnyvale, CA, US

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