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FDA 510(k) Application Details - K973316
Device Classification Name
Electrophoretic, Protein Fractionation
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510(K) Number
K973316
Device Name
Electrophoretic, Protein Fractionation
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT, TX 77704 US
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Contact
PAT FRANKS
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Regulation Number
862.1630
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Classification Product Code
CEF
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More FDA Info for this Product Code
Date Received
09/03/1997
Decision Date
10/01/1997
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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