FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Test, Her-2/Neu, Nucleic Acid Or Serum
PMA: P040005
·
Supplement: S001
·
Decision Apr 21, 2006
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- System, Test, Her-2/Neu, Nucleic Acid Or Serum
- Trade Name
- HER2 FISH PHARMDX KIT
- PMA Number
- P040005
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MVD
- Generic Name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 21, 2006
- Date Received
- August 15, 2005
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARKS A/S, GLOSTRUP, DENMARK.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | FDA class 3 | Unknown |