PMA P050045S001

Device: TOP2A FISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S001
Product code: NXG
Decision date: 2008-02-13
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Approval order statement: APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.

Current openFDA PMA Record#

Device: TOP2A FISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P050045
Supplement: S001
Product code: NXG
Generic name: Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Decision date: 2008-02-13
Decision code: APPR
Date received: 2008-01-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.