ETEST LINEZOLID— 510(k) K002139
Substantially EquivalentAb Biodisk
FDA 510(k) clearance K002139 for ETEST LINEZOLID, Substantially Equivalent on 2000-11-08. Applicant: Ab Biodisk. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk
- Product code
- Code LTX
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Recent devices under product code LTX
view allMore clearances from Ab Biodisk
view all- K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
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- K042392 — DAPTOMYCIN
- K042390 — ETEST FOR GEMIFLOXACIN
- K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Data sourced from openFDA. This site is unofficial and independent of the FDA.