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ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K071706
510(k) Type
Traditional
Applicant
CLINICAL DATA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2007
Days to Decision
182 days
Submission Type
Summary

ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K071706
510(k) Type
Traditional
Applicant
CLINICAL DATA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/2007
Days to Decision
182 days
Submission Type
Summary