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510(k) K062585

MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN by Dade Behring, Inc. — Product Code LRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2006
Date Received
September 1, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES (September 10, 2010)
  • K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN (September 8, 2008)
  • K071316 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPT (August 20, 2007)
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