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FDA 510(k) Application Details - K062966
Device Classification Name
Lamotrigine Assay
More FDA Info for this Device
510(K) Number
K062966
Device Name
Lamotrigine Assay
Applicant
SERADYN INC.
7998 GEORGETOWN RD.
SUITE 1000
INDIANAPOLIS, IN 46268-5260 US
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Contact
JACK ROGERS
Other 510(k) Applications for this Contact
Regulation Number
862.3350
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Classification Product Code
ORH
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More FDA Info for this Product Code
Date Received
09/29/2006
Decision Date
01/12/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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