ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE


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 Number 866.3210
Classification Product Code
NGS  
Date Received 04/14/2003
Decision Date 06/16/2003
Decision

an

(AN)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Post-NSE

Reviewed by Third Party No

Combination Product

No