VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)— 510(k) K120466

Clearance details

Applicant

Nanosphere, Inc.

Product code

Code NTI

Device class

Class 2

Regulation

21 CFR 862.3360

Advisory panel

Clinical Toxicology

Date received

2012-02-15

Decision date

2012-11-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northbrook, IL, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120466.