PMA P110012S018
- Device
- Vysis ALK Break Apart FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S018
- Product code
- OWE
- Decision date
- 2019-05-08
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- Change to a critical reagent supplier’s location.
Current openFDA PMA Record#
- Device
- Vysis ALK Break Apart FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S018
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2019-05-08
- Decision code
- OK30
- Date received
- 2019-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a critical reagent supplier’s location.