FDA 510(k) Application Details - K760835

Device Classification Name Antiserum, Positive Control, Aspergillus Spp.

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510(K) Number K760835
Device Name Antiserum, Positive Control, Aspergillus Spp.
Applicant I M, INC.

, US
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Regulation Number 866.3040

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Classification Product Code KFG
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Date Received 10/13/1976
Decision Date 11/01/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee IM - Immunology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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