PMA P110012S003
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S003
- Product code
- OWE
- Decision date
- 2013-04-17
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S003
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2013-04-17
- Decision code
- OK30
- Date received
- 2013-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- THREE MANUFACTURING CHANGES, INCLUDING THE ADDITION OF A WORKING CELL BANK, IMPLEMENTATION OF A PRE-FERMENTATION OPTICAL DENSITY READING, AND MODIFICATION TO PROPAGATING THE CELL LINE USED TO MAKE NEGATIVE CONTROL SLIDES.