FDA 510(k) Application Details - K830005

Device Classification Name Igg, Peroxidase, Antigen, Antiserum, Control

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510(K) Number K830005
Device Name Igg, Peroxidase, Antigen, Antiserum, Control
Applicant DIAGNOSTIC REAGENT TECH.

, US
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Regulation Number 866.5510

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Classification Product Code DAA
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Date Received 01/03/1983
Decision Date 06/02/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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