RDI HS CRP KIT


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K021609
Device Name RDI HS CRP KIT
Original Applicant
REFERENCE DIAGNOSTICS, INC.
19 crosby dr. suite 30
bedford, 
MA 
01730

Original Contact joseph lawlor
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 05/16/2002
Decision Date 06/27/2002
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