PMA P040005S008
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S008
- Product code
- MVD
- Decision date
- 2012-07-31
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- MANUFACTURING PROCESS OF PNA OLIGOMERS IN THE DEVICE.
Current openFDA PMA Record#
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S008
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2012-07-31
- Decision code
- OK30
- Date received
- 2012-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS OF PNA OLIGOMERS IN THE DEVICE.