SENSITITRE AIM (TM)— 510(k) K110331
Substantially EquivalentTrek Diagnostic Systems, Ltd.
FDA 510(k) clearance K110331 for SENSITITRE AIM (TM), Substantially Equivalent on 2011-04-27. Applicant: Trek Diagnostic Systems, Ltd.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Ltd.
- 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
Recent devices under product code LIE
view allMore clearances from Trek Diagnostic Systems, Ltd.
view all- K110583 — SENSITITRE OPTIREAD
- K111429 — SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
- K093741 — SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
- K092445 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K062681 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Data sourced from openFDA. This site is unofficial and independent of the FDA.