FDA 510(k) Application Details - K771243

Device Classification Name Igg (Fab Fragment Specific), Antigen, Antiserum, Control

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510(K) Number K771243
Device Name Igg (Fab Fragment Specific), Antigen, Antiserum, Control
Applicant KENT LABORATORIES, INC.

, US
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Regulation Number 866.5520

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Classification Product Code DFK
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Date Received 07/11/1977
Decision Date 08/03/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee MI - Microbiology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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