VYSIS ALK BREAK APART FISH PROBE KIT
FDA premarket approval P110012/S007 · decided 2014-12-10
Approval details
- PMA number
- P110012
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2014-08-14
- Decision date
- 2014-12-10
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PROBECHK ALK POSITIVE AND NEGATIVE CONTROL SLIDE LABELING, AND EXPANSION OF THE ASSAY GUARD BAND PARAMETERS.
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