MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM— 510(k) K043589
Substantially EquivalentDade Microscan, Inc.
FDA 510(k) clearance K043589 for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM, Substantially Equivalent on 2005-02-14. Applicant: Dade Microscan, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Microscan, 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
- West Sacramento, CA, US
Recent devices under product code JWY
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- 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 Dade Microscan, Inc.
view all- K023202 — MICROSCAN SYNERGIES PLUS
- K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
- K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
- K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
- K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.