Cleared Abbreviated

ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

K110394 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry
Jun 2011
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K110394 is an FDA 510(k) clearance for the ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON), a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on June 9, 2011, 118 days after receiving the submission on February 11, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K110394 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2011
Decision Date June 09, 2011
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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