PMA P120019S004

Device: COBAS EGFR MUTATION TEST
Applicant: Roche
PMA number: P120019
Supplement: S004
Product code: OWD
Decision date: 2014-03-12
Classification: Somatic Gene Mutation Detection System
Generic name: Somatic gene mutation detection system
Approval order statement: APPROVAL FOR CHANGES TO THE COBAS 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS BRAF V600 MUTATION TEST AND COBAS EGFR MUTATION TEST.

Current openFDA PMA Record#

Device: COBAS EGFR MUTATION TEST
Applicant: Roche
PMA number: P120019
Supplement: S004
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2014-03-12
Decision code: APPR
Date received: 2013-12-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE COBAS 4800 SR2 SYSTEM SOFTWARE ARCHITECTURE AND ASSAY SPECIFIC ANALYSIS PACKAGE (ASAP) SOFTWARE FOR THE COBAS BRAF V600 MUTATION TEST AND COBAS EGFR MUTATION TEST.