PMA P120019S026

Device

cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

Applicant

Roche

PMA number

P120019

Supplement

S026

Product code

OWD

Decision date

2018-12-11

Classification

Somatic Gene Mutation Detection System

Generic name

Somatic gene mutation detection system

Approval order statement

Implementation of a cleaning process for pumps used in component manufacturing.

Summary

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