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VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

Page Type
Cleared 510(K)
510(k) Number
K031031
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2003
Days to Decision
181 days
Submission Type
Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

Page Type
Cleared 510(K)
510(k) Number
K031031
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/29/2003
Days to Decision
181 days
Submission Type
Summary