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510(k) K974881

TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A by Biosite Incorporated — Product Code MCB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1998
Date Received
December 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, C. Difficile
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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