THERASCREEN EGFR RGQ PCR KIT
FDA premarket approval P120022/S012 · decided 2015-11-09
Approval details
- PMA number
- P120022
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERASCREEN EGFR RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2015-09-28
- Decision date
- 2015-11-09
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT QIAGEN GMBH IN HILDEN, GERMANY.
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