PMA P110012S008
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S008
- Product code
- OWE
- Decision date
- 2014-08-14
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- REPLACEMENT OF THE FERMENTERS USED IN THE FERMENTATION PROCESSES.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S008
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2014-08-14
- Decision code
- OK30
- Date received
- 2014-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF THE FERMENTERS USED IN THE FERMENTATION PROCESSES.