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ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992029
510(k) Type
Traditional
Applicant
Elan Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/1999
Days to Decision
57 days
Submission Type
Summary

ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K992029
510(k) Type
Traditional
Applicant
Elan Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/12/1999
Days to Decision
57 days
Submission Type
Summary