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510(k) K041003

IMMUNOCARD TOXINS A & B, MODEL 712050 by Meridian Bioscience, Inc. — Product Code LLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2004
Date Received
April 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Clostridium Difficile Toxin
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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