- Device
- HER2 FISH PHARMADX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S009
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2013-02-22
- Decision code
- APPR
- Date received
- 2012-08-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITION OF KADCYLA (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HER2 IQ-FISH PHARMDX KIT.