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Direct HDL Cholesterol (HDL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153435
510(k) Type
Traditional
Applicant
Randox Laboratories Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/8/2016
Days to Decision
42 days
Submission Type
Summary

Direct HDL Cholesterol (HDL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153435
510(k) Type
Traditional
Applicant
Randox Laboratories Ltd
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/8/2016
Days to Decision
42 days
Submission Type
Summary