PMA P040005S007
- Device
- HER2 IQFISH PHARMDX
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S007
- Product code
- MVD
- Decision date
- 2012-12-05
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order 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.
Current openFDA PMA Record#
- Device
- HER2 IQFISH PHARMDX
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S007
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2012-12-05
- Decision code
- APPR
- Date received
- 2011-12-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.