FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
System, Test, Her-2/Neu, Ihc
PMA: P980018
·
Supplement: S002
·
Decision Jun 11, 2003
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- System, Test, Her-2/Neu, Ihc
- Trade Name
- DAKOCYTOMATION HERCEP TEST
- PMA Number
- P980018
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- MVC
- Generic Name
- SYSTEM, TEST, HER-2/NEU, IHC
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 11, 2003
- Date Received
- May 14, 2003
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE IN THE MANUFACTURING METHOD FOR THE CONJUGATION OF THE TWO PROTEINS TO THE ACTIVATED DEXTRAN TO ONE STEP FOLLOWED BY ONLY ONE PURIFICATION STEP.
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 |
|---|---|---|---|
| MVC | System, Test, Her-2/Neu, Ihc | FDA class 3 | Unknown |