FDA 510(k) Application Details - K053572

Device Classification Name Antigen, C. Difficile

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510(K) Number K053572
Device Name Antigen, C. Difficile
Applicant TECHLAB, INC.
2001 KRAFT DR.
BLACKSBURG, VA 24060-6358 US
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Contact DAVID M LYERLY
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Regulation Number 866.2660

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Classification Product Code MCB
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Date Received 12/22/2005
Decision Date 04/26/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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