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FDA 510(k) Application Details - K010325
Device Classification Name
Complement C4, Antigen, Antiserum, Control
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510(K) Number
K010325
Device Name
Complement C4, Antigen, Antiserum, Control
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND, VA 23237 US
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Contact
TONYA MALLORY
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Regulation Number
866.5240
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Classification Product Code
DBI
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Date Received
02/02/2001
Decision Date
06/25/2001
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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