FDA 510(k) Application Details - K963018

Device Classification Name Electrophoretic, Protein Fractionation

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510(K) Number K963018
Device Name Electrophoretic, Protein Fractionation
Applicant BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803 US
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Contact JOHN W NELSON
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Regulation Number 862.1630

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Classification Product Code CEF
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Date Received 08/02/1996
Decision Date 06/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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