VYSIS ALK BREAK APART FISH PROBE KIT
FDA premarket approval P110012/S013 · decided 2017-04-12
Approval details
- PMA number
- P110012
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2016-11-22
- Decision date
- 2017-04-12
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval for upgrades to the VP 2000 Processor.
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