PMA P110012S001
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S001
- Product code
- OWE
- Decision date
- 2012-06-07
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S001
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2012-06-07
- Decision code
- APPR
- Date received
- 2011-12-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892.