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DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050823
510(k) Type
Traditional
Applicant
TECO DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/26/2005
Days to Decision
117 days
Submission Type
Statement

DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050823
510(k) Type
Traditional
Applicant
TECO DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/26/2005
Days to Decision
117 days
Submission Type
Statement