VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS— 510(k) K013899

Clearance details

Applicant

Ortho-Clinical Diagnostics

Product code

Code CDD

Device class

Class 2

Regulation

21 CFR 862.1810

Advisory panel

Clinical Chemistry

Date received

2001-11-23

Decision date

2002-01-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013899.