PMA P110012S009
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S009
- Product code
- OWE
- Decision date
- 2015-07-02
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- APPROVAL FOR USE OF ABBOTT VP 2000 PROCESSOR AND A CORRESPONDING SET OFREAGENTS IN AN AUTOMATED SLIDE PROCESSING PROCEDURE.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S009
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2015-07-02
- Decision code
- APPR
- Date received
- 2014-10-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USE OF ABBOTT VP 2000 PROCESSOR AND A CORRESPONDING SET OFREAGENTS IN AN AUTOMATED SLIDE PROCESSING PROCEDURE.