THERASCREEN EGFR RGQ PCR KIT
FDA premarket approval P120022/S004 · decided 2015-01-15
Approval details
- PMA number
- P120022
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERASCREEN EGFR RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2014-12-15
- Decision date
- 2015-01-15
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- RELOCATION OF THE QUALITY CONTROL LABORATORIES WITHIN QIAGEN MANCHESTER LTD. SKELETON HOUSE FACILITY.
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