Vysis ALK Break Apart Fish Probe Kit
FDA premarket approval P110012/S015 · decided 2018-03-12
Approval details
- PMA number
- P110012
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vysis ALK Break Apart Fish Probe Kit
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2018-02-16
- Decision date
- 2018-03-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Changes to the manufacturing process and manufacturing site of a suppliers product.
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