THERASCREEN KRAS RGQ PCR KIT
FDA premarket approval P110027/S008 · decided 2015-08-06
Approval details
- PMA number
- P110027
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERASCREEN KRAS RGQ PCR KIT
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2015-02-18
- Decision date
- 2015-08-06
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- APPROVAL FOR THE CHANGE IN MANUFACTURING OF A CRITICAL REAGENT (TAQ POLYMERASE) AND THE CONVERSION OF A MANUAL REAGENT FILL PROCESS TO ONE THAT IS AUTOMATED.
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