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VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101921
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/2010
Days to Decision
105 days
Submission Type
Summary

VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K101921
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/2010
Days to Decision
105 days
Submission Type
Summary