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510(k) K020748

ETEST ERTAPENEM by Ab Biodisk — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2002
Date Received
March 7, 2002
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

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  • 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)
  • 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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  • 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)
  • 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)