SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)— 510(k) K882301
Substantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalytic
FDA 510(k) clearance K882301 for SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88), Substantially Equivalent on 1988-07-12. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.
Clearance details
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- 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
- Cockeysville, MD, US
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 Bd Becton Dickinson Vacutainer Systems Preanalytic
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