Cleared Traditional

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

K082638 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Feb 2009
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K082638 is an FDA 510(k) clearance for the ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on February 26, 2009, 169 days after receiving the submission on September 10, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K082638 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2008
Decision Date February 26, 2009
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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