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510(k) K031727

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN by Pasco Laboratories, Inc. — Product Code JWY

K031727 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN". The FDA issued a decision of Substantially Equivalent on July 30, 2003. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Pasco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2003
Date Received
June 3, 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 Pasco Laboratories, Inc.

  • K042331 — PASCO MIC AND MIC/ID PANELS (October 7, 2004)
  • K041776 — PASCO MIC AND MIC/ID PANELS (August 3, 2004)
  • K041214 — PASCO MIC AND MIC/ID PANELS (June 7, 2004)
  • K033119 — PASCO MIC AND MIC/ID PANELS (November 18, 2003)
  • K031205 — PASCO MIC AND MIC/ID PANELS (June 13, 2003)
  • K031103 — PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (June 12, 2003)
  • K030933 — PASCO MIC AND MIC/ID PANELS (May 1, 2003)
  • K030620 — PASCO MIC AND MIC/ID PANELS (April 14, 2003)
  • K020331 — PASCO MIC AND MIC/ID PANELS (March 20, 2002)
  • K011116 — PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST (April 24, 2001)

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