EON CALCIUM REGENT— 510(k) K120626

Clearance details

Applicant

Vital Diagnostics (Manufacturing) Ptyltd

Product code

Code CJY

Device class

Class 2

Regulation

21 CFR 862.1145

Advisory panel

Clinical Chemistry

Date received

2012-03-01

Decision date

2012-08-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Noble Park, AU

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120626.