FDA 510(k) Application Details - K960029

Device Classification Name Electrophoretic, Protein Fractionation

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510(K) Number K960029
Device Name Electrophoretic, Protein Fractionation
Applicant MORAX
13805 WATERLOO RD.
CHELSEA, MI 48118 US
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Contact JANIK BOREK
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Regulation Number 862.1630

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Classification Product Code CEF
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Date Received 01/02/1996
Decision Date 07/17/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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