VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS— 510(k) K030067

Clearance details

Applicant

Ortho-Clinical Diagnostics

Product code

Code MJX

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2003-01-07

Decision date

2003-01-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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• Z-0313-2017 — VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.Class III·Terminated·Ortho-Clinical Diagnostics·20160622

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030067.