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510(k) K984144

SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID by Ab Biodisk — Product Code JWY

K984144 is an FDA 510(k) premarket notification submitted by Ab Biodisk for the device "SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID". The FDA issued a decision of Substantially Equivalent on February 9, 1999. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Ab Biodisk has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1999
Date Received
November 18, 1998
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 Ab Biodisk

  • K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (July 24, 2008)
  • K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCU (October 13, 2005)
  • K042392 — DAPTOMYCIN (December 13, 2004)
  • K042390 — ETEST FOR GEMIFLOXACIN (November 19, 2004)
  • K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING (July 27, 2004)
  • K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (June 6, 2002)
  • K020748 — ETEST ERTAPENEM (April 29, 2002)
  • K010363 — ETEST MEROPENEM (April 9, 2001)
  • K002139 — ETEST LINEZOLID (November 8, 2000)
  • K001547 — ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (August 7, 2000)

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