DeviceClearance

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS— 510(k) K984321

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K984321 for VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS, Substantially Equivalent on 1999-01-22. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
Code CDD
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.