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VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K062838
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2006
Days to Decision
89 days
Submission Type
Summary

VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K062838
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2006
Days to Decision
89 days
Submission Type
Summary