FDA 510(k) Application Details - K042071

Device Classification Name Lactoferrin, Antigen, Antiserum, Control

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510(K) Number K042071
Device Name Lactoferrin, Antigen, Antiserum, Control
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 866.5570

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Classification Product Code DEG
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Date Received 08/02/2004
Decision Date 10/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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