CRP-LATEX (II)X2 SEIKEN ASSAY KIT


Device Classification Name

c-reactive protein, antigen, antiserum, and control

510(k) Number K030545
Device Name CRP-LATEX (II)X2 SEIKEN ASSAY KIT
Applicant
DENKA SEIKEN CO., LTD.
kagamida facility
1-2-2 minamihoncho,
gosen city, niigata, 

JP

959-1695

Applicant Contact toshimi matsunaga
Correspondent
DENKA SEIKEN CO., LTD.
kagamida facility
1-2-2 minamihoncho,
gosen city, niigata, 

JP

959-1695

Correspodent Contact toshimi matsunaga
Regulation Number 866.5270
Classification Product Code
DCK  
Date Received 02/20/2003
Decision Date 06/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No