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510(k) K093604

ETEST MOXIFLOXACIN 0.002-32 UG/ML by Ab Biomerieux — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2010
Date Received
November 20, 2009
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 Biomerieux

  • K082534 — ETEST VORICONAZOLE 0.002-32 UG/ML (November 2, 2009)

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