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VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II

Page Type
Cleared 510(K)
510(k) Number
K041720
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2004
Days to Decision
62 days
Submission Type
Summary

VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II

Page Type
Cleared 510(K)
510(k) Number
K041720
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/2004
Days to Decision
62 days
Submission Type
Summary