FDA 510(k) Application Details - K960257

Device Classification Name Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

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510(K) Number K960257
Device Name Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Applicant BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD, MA 02090 US
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Contact KATHLEEN DRAY-LYONS
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Regulation Number 866.5250

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Classification Product Code DBA
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Date Received 01/18/1996
Decision Date 08/01/1996
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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