PMA P140023S003

Device: COBAS KRAS MUTATION TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S003
Product code: OWD
Decision date: 2016-04-25
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for the proposed formulation change (removal of anti-microbial agent ProClin 300) and process changes to production of KRAS reaction Mix, a component of cobas® KRAS Mutation Test.

Current openFDA PMA Record#

Device: COBAS KRAS MUTATION TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S003
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2016-04-25
Decision code: APPR
Date received: 2016-01-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the proposed formulation change (removal of anti-microbial agent ProClin 300) and process changes to production of KRAS reaction Mix, a component of cobas® KRAS Mutation Test.