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FDA 510(k) Application Details - K022053
Device Classification Name
Electrophoretic Separation, Lipoproteins
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510(K) Number
K022053
Device Name
Electrophoretic Separation, Lipoproteins
Applicant
SEBIA
13805 WATERLOO
CHELSEA, MI 48118 US
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Contact
BOREK JANIK
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Regulation Number
862.1475
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Classification Product Code
JHO
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More FDA Info for this Product Code
Date Received
06/24/2002
Decision Date
07/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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