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PMA P120019S031

Device
cobas EGFR Mutation Test v2
Applicant
Roche
Product code
OWD
Decision date
2020-10-27
Generic name
Somatic gene mutation detection system
Approval order statement
Approval for cobas® EGFR Mutation Test v2 label expansion to obtain companion diagnostic group labeling claim for EGFR Tyrosine Kinase Inhibitors (TKI) for specific EGFR mutations detected by the test.

Current openFDA PMA Record#

Device
cobas EGFR Mutation Test v2
Applicant
Roche
PMA number
P120019
Supplement
S031
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2020-10-27
Decision code
APPR
Date received
2020-04-30
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for cobas® EGFR Mutation Test v2 label expansion to obtain companion diagnostic group labeling claim for EGFR Tyrosine Kinase Inhibitors (TKI) for specific EGFR mutations detected by the test.