SENSITITRE OPTIREAD— 510(k) K110583
Substantially EquivalentTrek Diagnostic Systems, Ltd.
FDA 510(k) clearance K110583 for SENSITITRE OPTIREAD, Substantially Equivalent on 2011-09-22. Applicant: Trek Diagnostic Systems, Ltd.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Ltd.
- Product code
- Code LRG
- 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.