THE SENSITITRE AIM— 510(k) K103456
Substantially EquivalentTrek Diagnostic Systems
FDA 510(k) clearance K103456 for THE SENSITITRE AIM, Substantially Equivalent on 2011-06-22. Applicant: Trek Diagnostic Systems. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems
- Product code
- Code LIE
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
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