ETEST VORICONAZOLE 0.002-32 UG/ML— 510(k) K082534
Substantially EquivalentAb Biomerieux
FDA 510(k) clearance K082534 for ETEST VORICONAZOLE 0.002-32 UG/ML, Substantially Equivalent on 2009-11-02. Applicant: Ab Biomerieux. Device class: 2.
Clearance details
- Applicant
- Ab Biomerieux
- 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
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More clearances from Ab Biomerieux
view allData sourced from openFDA. This site is unofficial and independent of the FDA.