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510(k) K010363

ETEST MEROPENEM by Ab Biodisk — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2001
Date Received
February 7, 2001
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

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  • 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)
  • 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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