THERASCREEN EGFR RGQ PCR KIT
FDA premarket approval P120022/S007 · decided 2015-02-19
Approval details
- PMA number
- P120022
- Supplement
- S007
- 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
- 2015-01-21
- Decision date
- 2015-02-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- CHANGE OF FILLING PROCESS FOR PROTEINASE K IN THE QIAAMP DSP DNA FFPE TISSUE KIT FROM A MANUAL TO AN AUTOMATED PROCESS AT THE HILDEN, GERMANY FACILITY.
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