510(k) K163260

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 17, 2017

Date Received

November 21, 2016

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Device Class

Class II

Regulation Number

866.3215

Review Panel

MI

Submission Type

A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.