Cleared Traditional

EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

K100829 · Medica Corp. · Chemistry
Jan 2011
Decision
296d
Days
Class 2
Risk

About This 510(k) Submission

K100829 is an FDA 510(k) clearance for the EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on January 14, 2011, 296 days after receiving the submission on March 24, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K100829 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2010
Decision Date January 14, 2011
Days to Decision 296 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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