Cleared Traditional

PROLYTE ELECTROLYTE ANALYZER

K121140 · Diamond Diagnostics, Inc. · Chemistry
Aug 2012
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K121140 is an FDA 510(k) clearance for the PROLYTE ELECTROLYTE ANALYZER, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on August 22, 2012, 128 days after receiving the submission on April 16, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K121140 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2012
Decision Date August 22, 2012
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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