PMA P140023S030

Device: Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S030
Product code: OWD
Decision date: 2024-05-15
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.

Current openFDA PMA Record#

Device: Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit
Applicant: Roche Molecular Systems, Inc.
PMA number: P140023
Supplement: S030
Product code: OWD
Generic name: Somatic gene mutation detection system
Decision date: 2024-05-15
Decision code: APPR
Date received: 2024-04-26
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.