VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
FDA premarket approval P110012/S009 · decided 2015-07-02
Approval details
- PMA number
- P110012
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2014-10-01
- Decision date
- 2015-07-02
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- OWE
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR USE OF ABBOTT VP 2000 PROCESSOR AND A CORRESPONDING SET OFREAGENTS IN AN AUTOMATED SLIDE PROCESSING PROCEDURE.
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