Cleared Traditional

URIC ACID (AOX), SCAL, NORTROL, ABTROL

K073612 · Thermofisher Scientific OY · Chemistry
May 2008
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K073612 is an FDA 510(k) clearance for the URIC ACID (AOX), SCAL, NORTROL, ABTROL, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on May 23, 2008, 154 days after receiving the submission on December 21, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K073612 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2007
Decision Date May 23, 2008
Days to Decision 154 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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