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MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020662
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/12/2002
Days to Decision
42 days
Submission Type
Summary

MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K020662
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/12/2002
Days to Decision
42 days
Submission Type
Summary