RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K021194
Device Name RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
Original Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 red branch rd.
columbia, 
MD 
21045

Original Contact jose a montanez
Regulation Number 866.5270
Classification Product Code
DCK  
Subsequent Product Code
JIS  
Date Received 04/15/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No