PMA P040005S014
- Device
- HER2 IQFISH pharmDx
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S014
- Product code
- MVD
- Decision date
- 2017-04-12
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- Changes to the in-process control fluorescent labeling process.
Current openFDA PMA Record#
- Device
- HER2 IQFISH pharmDx
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S014
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2017-04-12
- Decision code
- OK30
- Date received
- 2017-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the in-process control fluorescent labeling process.