HER2 CISH PHARMDX KIT
FDA premarket approval P100024/S008 · decided 2016-01-29
Approval details
- PMA number
- P100024
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HER2 CISH PHARMDX KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Dako Denmark A/S
- Date received
- 2016-01-08
- Decision date
- 2016-01-29
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- 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.
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