PMA P090015S001

Device: BOND ORACLE HER2 IHC SYSTEM
Applicant: Leica Biosystems
PMA number: P090015
Supplement: S001
Product code: MVC
Decision date: 2014-02-11
Classification: System, Test, Her-2/neu, Ihc
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.

Current openFDA PMA Record#

Device: BOND ORACLE HER2 IHC SYSTEM
Applicant: Leica Biosystems
PMA number: P090015
Supplement: S001
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Decision date: 2014-02-11
Decision code: APPR
Date received: 2013-07-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.