FDA 510(k) Application Details - K863868

Device Classification Name Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

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510(K) Number K863868
Device Name Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
Applicant COOPERBIOMEDICAL, INC.
ONE TECHNOLOGY COURT
MALVERN, PA US
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Contact BREWSTER, PHD
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Regulation Number 866.5080

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Classification Product Code DFF
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Date Received 10/03/1986
Decision Date 02/13/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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