Last synced on 17 March 2023 at 11:04 pm

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013899
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/2002
Days to Decision
62 days
Submission Type
Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K013899
510(k) Type
Traditional
Applicant
ORTHO-CLINICAL DIAGNOSTICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/2002
Days to Decision
62 days
Submission Type
Summary