PMA P980024S007

Device: PATH VYSION HER-2 DNA PROBE KIT ASSAY
Applicant: Abbott Molecular, Inc.
PMA number: P980024
Supplement: S007
Product code: MVD
Decision date: 2012-12-20
Classification: System, Test, Her-2/neu, Nucleic Acid Or Serum
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Approval order statement: APPROVAL FOR THE MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.

Current openFDA PMA Record#

Device: PATH VYSION HER-2 DNA PROBE KIT ASSAY
Applicant: Abbott Molecular, Inc.
PMA number: P980024
Supplement: S007
Product code: MVD
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Decision date: 2012-12-20
Decision code: APPR
Date received: 2012-06-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.