K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE


codes

Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K002558
Device Name K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
Original Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Original Contact colin getty
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 08/14/2000
Decision Date 10/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Special
Reviewed by Third Party No

Combination Product

No