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Direct LDL Cholesterol (LDL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161691
510(k) Type
Traditional
Applicant
RANDOX LABORATORIES LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
3/20/2017
Days to Decision
273 days
Submission Type
Summary

Direct LDL Cholesterol (LDL)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161691
510(k) Type
Traditional
Applicant
RANDOX LABORATORIES LIMITED
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
3/20/2017
Days to Decision
273 days
Submission Type
Summary