Cleared Traditional

ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator

K153365 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Dec 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K153365 is an FDA 510(k) clearance for the ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on December 18, 2015, 28 days after receiving the submission on November 20, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K153365 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2015
Decision Date December 18, 2015
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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