PMA P110012S015
- Device
- Vysis ALK Break Apart Fish Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S015
- Product code
- OWE
- Decision date
- 2018-03-12
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- Changes to the manufacturing process and manufacturing site of a suppliers product.
Current openFDA PMA Record#
- Device
- Vysis ALK Break Apart Fish Probe Kit
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S015
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2018-03-12
- Decision code
- OK30
- Date received
- 2018-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing process and manufacturing site of a suppliers product.