ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2— 510(k) K110830

Clearance details

Device name as filed

ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

Applicant

Elitechgroup

Product code

Code CIX

Device class

Class 2

Regulation

21 CFR 862.1035

Advisory panel

Clinical Chemistry

Date received

2011-03-25

Decision date

2011-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bothell, WA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110830.