FDA 510(k) Application Details - K833396

Device Classification Name Radioimmunoassay, C-Peptides Of Proinsulin

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510(K) Number K833396
Device Name Radioimmunoassay, C-Peptides Of Proinsulin
Applicant SERONO DIAGNOSTICS, INC.


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Regulation Number 862.1135

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Classification Product Code JKD
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Date Received 09/30/1983
Decision Date 04/13/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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