PMA P100024S008

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S008
Product code: NYQ
Decision date: 2016-01-29
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.

Current openFDA PMA Record#

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S008
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2016-01-29
Decision code: OK30
Date received: 2016-01-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.