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VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142595
510(k) Type
Traditional
Applicant
Ortho Clinical Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/2015
Days to Decision
262 days
Submission Type
Summary

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K142595
510(k) Type
Traditional
Applicant
Ortho Clinical Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/4/2015
Days to Decision
262 days
Submission Type
Summary