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
|
|
Correspondent Contact |
TOSHIMI MATSUNAGA |
Regulation Number | 866.5270
|
Classification Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|