therascreen KRAS RGQ PCR Kit
FDA premarket approval P110027/S010 · decided 2018-04-06
Approval details
- PMA number
- P110027
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- therascreen KRAS RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2018-03-08
- Decision date
- 2018-04-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Change the supplier and the polymer used for a kit consumable.
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