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510(k) K043589

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM by Dade Microscan, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2005
Date Received
December 28, 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 Dade Microscan, Inc.

  • K023202 — MICROSCAN SYNERGIES PLUS (October 23, 2002)
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  • K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN (June 17, 2002)
  • K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL (June 11, 2002)
  • K021110 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (June 6, 2002)
  • K021188 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (June 6, 2002)
  • K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (June 6, 2002)
  • K021169 — MICROSTREP PLUS PANEL, AZITHROMYCIN (June 6, 2002)
  • K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (June 6, 2002)
  • K020938 — MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM (June 3, 2002)

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