Cleared Traditional

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

K132638 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jan 2014
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K132638 is an FDA 510(k) clearance for the DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on January 27, 2014, 157 days after receiving the submission on August 23, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K132638 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2013
Decision Date January 27, 2014
Days to Decision 157 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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