FDA.reportPublic FDA data

PMA P090015S004

Device
BOND ORACLE HER2 IHC SYSTEM
Applicant
Leica Biosystems
PMA number
P090015
Supplement
S004
Product code
MVC
Decision date
2017-02-15
Classification
System, Test, Her-2/neu, Ihc
Generic name
SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement
Transfer of several items of equipment from one testing laboratory to another laboratory within the same manufacture site. The equipment is used to complete the Quality Control testing of the BOND Oracle HER2 IHC System.

Current openFDA PMA Record#

Device
BOND ORACLE HER2 IHC SYSTEM
Applicant
Leica Biosystems
PMA number
P090015
Supplement
S004
Product code
MVC
Generic name
SYSTEM, TEST, HER-2/NEU, IHC
Decision date
2017-02-15
Decision code
OK30
Date received
2017-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer of several items of equipment from one testing laboratory to another laboratory within the same manufacture site. The equipment is used to complete the Quality Control testing of the BOND Oracle HER2 IHC System.