K-ASSAY CRP


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K991224
Device Name K-ASSAY CRP
Applicant
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Applicant Contact colin getty
Correspondent
KAMIYA BIOMEDICAL CO.
910 industry dr.
seattle, 
WA 
98188 -3412

Correspodent Contact colin getty
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 04/12/1999
Decision Date 05/14/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No