EXTENDED RANGE HS CRP KIT, CAT NO:9200


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K030044
Device Name EXTENDED RANGE HS CRP KIT, CAT NO:9200
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 01/06/2003
Decision Date 09/30/2003
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