FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Susceptibility Test Cards, Antimicrobial
PMA: N50510
·
Supplement: S071
·
Decision Dec 20, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Susceptibility Test Cards, Antimicrobial
- Trade Name
- VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
- PMA Number
- N50510
- Supplement Number
- S071
- Device Class
- FDA Class 2
- Product Code
- LTW
- Generic Name
- Susceptibility test cards, antimicrobial
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 20, 1996
- Date Received
- September 9, 1996
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MEROPENEM TO BE INCLUDED ON THE GRAM NEGATIVE SUSCEPTIBILITY CARD IN THREE CONCENTRATIONS (EQUIVALENT TO 2, 4, AND 8UG/ML).
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 |
|---|---|---|---|
| LTW | Susceptibility Test Cards, Antimicrobial | FDA class 2 | Microbiology |