Cleared Traditional

DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435

K093441 · Siemens Healthcare Diagnostics · Chemistry
Apr 2010
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K093441 is an FDA 510(k) clearance for the DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 7, 2010, 153 days after receiving the submission on November 5, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K093441 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2009
Decision Date April 07, 2010
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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