PMA P110012S013
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S013
- Product code
- OWE
- Decision date
- 2017-04-12
- 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 upgrades to the VP 2000 Processor.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S013
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2017-04-12
- Decision code
- APPR
- Date received
- 2016-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for upgrades to the VP 2000 Processor.