SENSITITRE YEASTONE SUSCEPTIBILITY PLATES— 510(k) K090968
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K090968 for SENSITITRE YEASTONE SUSCEPTIBILITY PLATES, Substantially Equivalent on 2009-06-04. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- Product code
- Code NGZ
- 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 NGZ
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- K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
- K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
- K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
More clearances from Trek Diagnostic Systems, Inc.
view allRecalls naming K090968
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090968.
Data sourced from openFDA. This site is unofficial and independent of the FDA.