DAKOCYTOMATION HER2 FISH PHARMDX KIT
FDA premarket approval P040005/S013 · decided 2016-04-12
Approval details
- PMA number
- P040005
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DAKOCYTOMATION HER2 FISH PHARMDX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2016-03-16
- Decision date
- 2016-04-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- Changes to the DNA propagation and purification processes.
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