FDA 510(k) Application Details - K771879

Device Classification Name Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

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510(K) Number K771879
Device Name Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Applicant HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES

, US
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Regulation Number 866.5420

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Classification Product Code DEN
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Date Received 10/04/1977
Decision Date 10/19/1977
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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