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510(k) K042392

DAPTOMYCIN by Ab Biodisk — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2004
Date Received
September 2, 2004
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)
  • 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)
  • K000596 — ETEST GATIFLOXACIN (May 22, 2000)

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  • 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)
  • K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomyci (May 22, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)