PMA P040005S001
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S001
- Product code
- MVD
- Decision date
- 2006-04-21
- Classification
- System, Test, Her-2/neu, Nucleic Acid Or Serum
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARKS A/S, GLOSTRUP, DENMARK.
Current openFDA PMA Record#
- Device
- HER2 FISH PHARMDX KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P040005
- Supplement
- S001
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2006-04-21
- Decision code
- APPR
- Date received
- 2005-08-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARKS A/S, GLOSTRUP, DENMARK.