ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE— 510(k) K021445
Substantially EquivalentAb Biodisk
FDA 510(k) clearance K021445 for ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE, Substantially Equivalent on 2002-06-06. 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
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 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
- K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Data sourced from openFDA. This site is unofficial and independent of the FDA.