← FDA Medical Device Classifications
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
SAN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1650
Classification
- FDA Product Code
SAN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.1650
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Market data
- Cleared 510(k) submissions
- 6
- Registered establishments
- 7
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown