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FDA 510(k) Application Details - K022455
Device Classification Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
More FDA Info for this Device
510(K) Number
K022455
Device Name
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT, TX 77704 US
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Contact
PATRICIA FRANKS
Other 510(k) Applications for this Contact
Regulation Number
862.1445
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Classification Product Code
CFE
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More FDA Info for this Product Code
Date Received
07/26/2002
Decision Date
10/01/2002
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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