FDA 510(k) Application Details - K051927

Device Classification Name Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)

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510(K) Number K051927
Device Name Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)
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 866.5785

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Classification Product Code NBT
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Date Received 07/18/2005
Decision Date 04/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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