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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name assay, endotoxin activity, chemiluminescent
De Novo Number DEN030002
510(K) Number K021885
Device Name ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
Requester
spectral diagnostics, inc.
16809 briardale rd.
rockville,  MD  20855
Contact tom tsakeris
Regulation Number866.3210
Classification Product Code
NGS  
Date Received04/14/2003
Decision Date 06/16/2003
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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