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510(k) K032518

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

K032518 is an FDA 510(k) premarket notification submitted by Bd Diagnostic Systems for the device "PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)". The FDA issued a decision of Substantially Equivalent on September 15, 2003. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Bd Diagnostic Systems has at least 5 other 510(k) clearances on record.

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

  • K260213 — BD BACTEC FXI Culture System (May 28, 2026)
  • K032153 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (September 11, 2003)
  • 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)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • 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)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)

FDA data resources