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510(k) K032518

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) by Bd Diagnostic Systems — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2003
Date Received
August 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Bd Diagnostic Systems

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  • K032259 — PASCO MIC AND MIC/ID PANELS (August 19, 2003)
  • K031429 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (June 6, 2003)
  • K030091 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML (February 28, 2003)

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  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
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  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)