ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
FDA premarket approval P140023/S002 · decided 2015-09-24
Approval details
- PMA number
- P140023
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2015-09-02
- Decision date
- 2015-09-24
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL OF GE HEALTHCARE SOURCED MATERIAL MANUFACTURED AT THE THERMOFISHER SCIENTIFIC FACILITY LOCATED IN VILNIUS, LITHUANIA AS AN APPROVED SUPPLIER OF POLYADENYLIC ACID POLYMER, POTASSIUM SALT (POLY A) FOR THE ROCHE MOLECULAR SYSTEMS FACILITY IN BRANCHBURG, NEW JERSEY.
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