PMA P120019S038

Device: Roche cobas EFGR Mutation Test, v2.0
Applicant: Roche
PMA number: P120019
Supplement: S038
Product code: OWD
Decision date: 2023-12-21
Classification: Pathology
Generic name: Somatic gene mutation detection system
Approval order statement: Approval for described labeling changes in an update to the hazard information on the product labeling for cobas® KRAS Mutation Test and the cobas® DNASample Preparation Kit.

Current openFDA PMA Record#

Device: Roche cobas EFGR Mutation Test, v2.0
Applicant: Roche
PMA number: P120019
Supplement: S038
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2023-12-21
Decision code: APPR
Date received: 2023-12-07
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for described labeling changes in an update to the hazard information on the product labeling for cobas® KRAS Mutation Test and the cobas® DNASample Preparation Kit.