ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA— 510(k) K052366
Substantially EquivalentAb Biodisk
FDA 510(k) clearance K052366 for ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA, Substantially Equivalent on 2005-10-13. Applicant: Ab Biodisk. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk
- Product code
- Code JWY
- 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 JWY
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- K260696 — MTS Gepotidacin 0.016-256 µg/mL
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
More clearances from Ab Biodisk
view allData sourced from openFDA. This site is unofficial and independent of the FDA.