FDA 510(k) Application Details - K831902

Device Classification Name Albumin, Fitc, Antigen, Antiserum, Control

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510(K) Number K831902
Device Name Albumin, Fitc, Antigen, Antiserum, Control
Applicant DAKO CORP.

, US
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Regulation Number 866.5040

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Classification Product Code DDZ
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Date Received 06/14/1983
Decision Date 07/18/1983
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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