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HDL-EX SEIKEN ASSAY KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041090
510(k) Type
Traditional
Applicant
DENKA SEIKEN CO., LTD.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
10/29/2004
Days to Decision
186 days
Submission Type
Summary

HDL-EX SEIKEN ASSAY KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K041090
510(k) Type
Traditional
Applicant
DENKA SEIKEN CO., LTD.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
10/29/2004
Days to Decision
186 days
Submission Type
Summary