XPERT C. DIFFICILE— 510(k) K091109

Substantially Equivalent

Cepheid

FDA 510(k) clearance K091109 for XPERT C. DIFFICILE, Substantially Equivalent on 2009-07-09. Applicant: Cepheid. Device class: 1.

Clearance details

Applicant: Cepheid
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2009-04-16
Decision date: 2009-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
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.