SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES— 510(k) K960235
Substantially EquivalentAccumed Intl., Inc.
FDA 510(k) clearance K960235 for SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES, Substantially Equivalent on 1996-03-27. Applicant: Accumed Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Accumed Intl., 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
- Westlake, OH, 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 Accumed Intl., Inc.
view all- K984489 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K983306 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
- K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
- K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
- K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.