Cleared Traditional

PROLYTE ELECTROLYTE ANALYZER

K102959 · Diamond Diagnostics, Inc. · Chemistry
Jan 2011
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K102959 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 January 14, 2011, 101 days after receiving the submission on October 5, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K102959 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2010
Decision Date January 14, 2011
Days to Decision 101 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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