VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)— 510(k) K140083

Substantially Equivalent

Nanosphere, Inc.

FDA 510(k) clearance K140083 for VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP), Substantially Equivalent on 2014-06-20. Applicant: Nanosphere, Inc..

Clearance details

Applicant: Nanosphere, Inc.
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2014-01-13
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.