CRP (II) CALIBRATORS


Device Classification Name

calibrator, primary

510(k) Number K030546
Device Name CRP (II) CALIBRATORS
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 862.1150
Classification Product Code
JIS  
Date Received 02/20/2003
Decision Date 06/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No