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FDA 510(k) Application Details - K071712
Device Classification Name
Lactoferrin, Antigen, Antiserum, Control
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510(K) Number
K071712
Device Name
Lactoferrin, Antigen, Antiserum, Control
Applicant
TECHLAB INC., CORPORATE RESEARCH CENTER
2001 KRAFT DR.
BLACKSBURG, VA 24060-6358 US
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Contact
CHARLES PENNINGTON
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Regulation Number
866.5570
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Classification Product Code
DEG
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More FDA Info for this Product Code
Date Received
06/22/2007
Decision Date
12/04/2007
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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