Cleared Traditional

VITAL SERUM CONTROLS

K111063 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry
Jun 2011
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K111063 is an FDA 510(k) clearance for the VITAL SERUM CONTROLS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park Victoria, AT). The FDA issued a Cleared decision on June 28, 2011, 71 days after receiving the submission on April 18, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K111063 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2011
Decision Date June 28, 2011
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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