FDA 510(k) Application Details - K830911

Device Classification Name Transferrin, Antigen, Antiserum, Control

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510(K) Number K830911
Device Name Transferrin, Antigen, Antiserum, Control
Applicant BIOCELL LABORATORIES, INC.

, US
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Regulation Number 866.5880

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Classification Product Code DDG
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Date Received 03/21/1983
Decision Date 06/10/1983
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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