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VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061588
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/2006
Days to Decision
43 days
Submission Type
Summary

VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K061588
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/2006
Days to Decision
43 days
Submission Type
Summary