HER2 IQFISH PHARMDX
FDA premarket approval P040005/S011 · decided 2015-09-10
Approval details
- PMA number
- P040005
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2015-08-13
- Decision date
- 2015-09-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- ALTERNATE WAREHOUSE ESTABLISHED WITHIN THE CURRENT FACILITY. THE CHANGE IS BEING MADE FOR THE STORAGE OF FINISHED DEVICES AFTER THEY HAVE BEEN QA RELEASED.
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