VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)— 510(k) K123197

Substantially Equivalent

Nanosphere, Inc.

FDA 510(k) clearance K123197 for VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF), Substantially Equivalent on 2012-12-05. Applicant: Nanosphere, Inc..

Clearance details

Applicant: Nanosphere, Inc.
Product code: 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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