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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, endotoxin activity, chemiluminescent
510(k) Number DEN030002
Device Name ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
Original Applicant
SPECTRAL DIAGNOSTICS, INC.
16809 briardale rd.
rockville,  MD  20855
Original Contact tom tsakeris
Regulation Number866.3210
Classification Product Code
NGS  
Date Received04/14/2003
Decision Date 06/16/2003
Decision (AN)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Post-NSE
Reviewed by Third Party No
Combination Product No
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