HER2 FISH PHARMDX KIT
FDA premarket approval P040005/S001 · decided 2006-04-21
Approval details
- PMA number
- P040005
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- HER2 FISH PHARMDX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2005-08-15
- Decision date
- 2006-04-21
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARKS A/S, GLOSTRUP, DENMARK.
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