PMA P110012S006
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S006
- Product code
- OWE
- Decision date
- 2014-07-16
- Classification
- Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Approval order statement
- MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S006
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2014-07-16
- Decision code
- OK30
- Date received
- 2014-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.