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FDA 510(k) Application Details - K020625
Device Classification Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
More FDA Info for this Device
510(K) Number
K020625
Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT, TX 77704 US
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Contact
PATRICIA FRANKS
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Regulation Number
862.1050
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Classification Product Code
CIN
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More FDA Info for this Product Code
Date Received
02/26/2002
Decision Date
05/06/2002
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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