PMA P110012S007
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S007
- Product code
- OWE
- Decision date
- 2014-12-10
- 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 MODIFICATIONS TO THE PROBECHK ALK POSITIVE AND NEGATIVE CONTROL SLIDE LABELING, AND EXPANSION OF THE ASSAY GUARD BAND PARAMETERS.
Current openFDA PMA Record#
- Device
- VYSIS ALK BREAK APART FISH PROBE KIT
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P110012
- Supplement
- S007
- Product code
- OWE
- Generic name
- Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
- Decision date
- 2014-12-10
- Decision code
- APPR
- Date received
- 2014-08-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE PROBECHK ALK POSITIVE AND NEGATIVE CONTROL SLIDE LABELING, AND EXPANSION OF THE ASSAY GUARD BAND PARAMETERS.