FDA 510(k) Application Details - K841814

Device Classification Name Igm, Antigen, Antiserum, Control

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510(K) Number K841814
Device Name Igm, Antigen, Antiserum, Control
Applicant MILES LABORATORIES, INC.

, US
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Regulation Number 866.5550

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Classification Product Code DFT
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Date Received 05/01/1984
Decision Date 06/22/1984
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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