PMA P100024S007

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S007
Product code: NYQ
Decision date: 2015-09-10
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.

Current openFDA PMA Record#

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S007
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2015-09-10
Decision code: OK30
Date received: 2015-08-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.