Cleared Traditional

CREATININE

K061193 · Abbott Laboratories, Inc. · Chemistry
Jun 2006
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K061193 is an FDA 510(k) clearance for the CREATININE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Abbott Laboratories, Inc. (Irving, US). The FDA issued a Cleared decision on June 23, 2006, 56 days after receiving the submission on April 28, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K061193 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2006
Decision Date June 23, 2006
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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