PMA P040005S012
- Device
- HER2 IQFISH PHARMDX
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S012
- Product code
- MVD
- Decision date
- 2016-01-29
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.
Current openFDA PMA Record#
- Device
- HER2 IQFISH PHARMDX
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S012
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2016-01-29
- Decision code
- OK30
- Date received
- 2016-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF THE IN-PROCESS QC "METAPHASE FISH TEST', WITH CHANGE NUMBER R02285. PMA APPROVED DEVICES AFFECTED BY THE CHANGE ARE: HER2 CISH PHARMDX KIT AND HER2 IQFISH PHARMDX.