VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY— 510(k) K072443

Clearance details

Applicant

Ortho-Clinical Diagnostics, Inc.

Product code

Code CJY

Device class

Class 2

Regulation

21 CFR 862.1145

Advisory panel

Clinical Chemistry

Date received

2007-08-30

Decision date

2007-09-24

Decision

Substantially Equivalent

Clearance type

Special

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 K072443.