Last synced on 4 February 2023 at 10:33 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K984321
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/1999
Days to Decision
50 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K984321
510(k) Type
Traditional
Applicant
Ortho-Clinical Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/1999
Days to Decision
50 days
Submission Type
Summary