FDA 510(k) Application Details - K833841

Device Classification Name Iga, Rhodamine, Antigen, Antiserum, Control

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510(K) Number K833841
Device Name Iga, Rhodamine, Antigen, Antiserum, Control
Applicant INSTRUMENTATION LABORATORY CO.

, US
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Regulation Number 866.5510

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Classification Product Code CZK
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Date Received 11/07/1983
Decision Date 01/04/1984
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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