FDA 510(k) Application Details - K100307

Device Classification Name	Electrophoretic, Lactate Dehydrogenase Isoenzymes   More FDA Info for this Device
510(K) Number	K100307
Device Name	Electrophoretic, Lactate Dehydrogenase Isoenzymes
Applicant	SEBIA 1705 CORPORATE DRIVE SUITE 400 NORCROSS, GA 30093 US Other 510(k) Applications for this Company
Contact	KAREN ANDERSON Other 510(k) Applications for this Contact
Regulation Number	862.1445   More FDA Info for this Regulation Number
Classification Product Code	CFE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2010
Decision Date	08/31/2010
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