PMA P050045S002

Device: TOP2A FISH PHARMDX
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S002
Product code: NXG
Decision date: 2008-03-26
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Approval order statement: CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.

Current openFDA PMA Record#

Device: TOP2A FISH PHARMDX
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S002
Product code: NXG
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Decision date: 2008-03-26
Decision code: OK30
Date received: 2008-03-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.