FDA 510(k) Application Details - K954145

Device Classification Name Complement C9, Antigen, Antiserum, Control

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510(K) Number K954145
Device Name Complement C9, Antigen, Antiserum, Control
Applicant WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND, VA US
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Contact TONYA MALLORY
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Regulation Number 866.5240

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Classification Product Code DAE
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Date Received 09/05/1995
Decision Date 12/18/1995
Decision SE - Substantially Equivalent
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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