K123197

Substantially Equivalent

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

Applicant: Nanosphere, Inc.
Product code: OZN
Advisory panel: Microbiology
Date received: 2012-10-11
Decision date: 2012-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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