PMA P110012S023
- Device
- Vysis ALK Break Apart FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S023
- Product code
- OWE
- Decision date
- 2026-02-18
- Classification
- Pathology
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- implementation of a secondary packaging process
Current openFDA PMA Record#
- Device
- Vysis ALK Break Apart FISH Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S023
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2026-02-18
- Decision code
- OK30
- Date received
- 2026-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a secondary packaging process