FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Panels, Test, Susceptibility, Antimicrobial
PMA: N50494
·
Supplement: S005
·
Decision Jun 30, 1982
Classifications
1
FEI Numbers
12
Registration Numbers
12
Basic Information
- Device Name
- Panels, Test, Susceptibility, Antimicrobial
- Trade Name
- MIC ANTIBIOTIC TEST PANELS
- PMA Number
- N50494
- Supplement Number
- S005
- Device Class
- FDA Class 2
- Product Code
- LTT
- Generic Name
- Panels, test, susceptibility, antimicrobial
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 30, 1982
- Date Received
- February 16, 1982
- Expedited Review
- N
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 |
|---|---|---|---|
| LTT | Panels, Test, Susceptibility, Antimicrobial | FDA class 2 | Microbiology |