BIORAPID MONONUCLEOSIS


Device Classification Name

system, test, infectious mononucleosis

510(k) Number K030215
Device Name BIORAPID MONONUCLEOSIS
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 866.5640
Classification Product Code
KTN  
Date Received 01/21/2003
Decision Date 02/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No