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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic, Lactate Dehydrogenase Isoenzymes
510(k) Number K100307
Device Name GELSCAN, MODEL 1206
Applicant
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Applicant Contact KAREN ANDERSON
Correspondent
Sebia
1705 Corporate Dr., Suite 400
Norcross,  GA  30093
Correspondent Contact KAREN ANDERSON
Regulation Number862.1445
Classification Product Code
CFE  
Subsequent Product Codes
CIN   JHY   JQT  
Date Received02/03/2010
Decision Date 08/31/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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