Cleared Traditional

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

K081731 · Siemens Healthcare Diagnostics · Chemistry
Aug 2008
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K081731 is an FDA 510(k) clearance for the DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on August 29, 2008, 71 days after receiving the submission on June 19, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K081731 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2008
Decision Date August 29, 2008
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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