HER2 IQFISH PHARMDX
FDA premarket approval P040005/S007 · decided 2012-12-05
Approval details
- PMA number
- P040005
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER2 IQFISH PHARMDX
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2011-12-14
- Decision date
- 2012-12-05
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR MODIFICATIONS TO THE FORMULATION OF THE HER2 FISH PHARMDX KIT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HER2 IQFISH PHARMDX.
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