ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING— 510(k) K040560
Substantially EquivalentAb Biodisk
FDA 510(k) clearance K040560 for ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING, Substantially Equivalent on 2004-07-27. Applicant: Ab Biodisk. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk
- 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
- Solna, SE
Recent devices under product code NGZ
view all- K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
- 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 Ab Biodisk
view all- K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
- K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
- K042392 — DAPTOMYCIN
- K042390 — ETEST FOR GEMIFLOXACIN
- K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
Recalls naming K040560
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 K040560.
Data sourced from openFDA. This site is unofficial and independent of the FDA.