DeviceClearance

VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST— 510(k) K070597

Substantially Equivalent

Nanosphere, Inc.

FDA 510(k) clearance K070597 for VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST, Substantially Equivalent on 2007-10-11. Applicant: Nanosphere, Inc..

Clearance details

Applicant
Nanosphere, Inc.
Product code
Code NSU
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Northbrook, IL, US
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