HEMOSIL C-REACTIVE PROTEIN – HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K023269
Device Name HEMOSIL C-REACTIVE PROTEIN – HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford, 
MA 
01730

Original Contact carol marble
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 10/01/2002
Decision Date 12/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No