PMA P100024S006

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S006
Product code: NYQ
Decision date: 2014-12-29
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: MODIFICATION OF THE QUALITY CONTROL FOR INCOMING ALU-PNAS MATERIALS TOREDUCE HIGH BACKGROUND SIGNAL IN THE NEGATIVE CONTROLS.

Current openFDA PMA Record#

Device: HER2 CISH PHARMDX KIT
Applicant: Dako Denmark A/S
PMA number: P100024
Supplement: S006
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2014-12-29
Decision code: OK30
Date received: 2014-12-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MODIFICATION OF THE QUALITY CONTROL FOR INCOMING ALU-PNAS MATERIALS TOREDUCE HIGH BACKGROUND SIGNAL IN THE NEGATIVE CONTROLS.