SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL— 510(k) K060783
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K060783 for SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL, Substantially Equivalent on 2006-05-16. Applicant: Trek Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- 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
- Cleveland, OH, US
Recent devices under product code JWY
view all- K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- 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 Trek Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.