Cleared Traditional

PROLYTE ELECTROLYTE ANALYZER

K070104 · Diamond Diagnostics, Inc. · Chemistry
May 2008
Decision
483d
Days
Class 2
Risk

About This 510(k) Submission

K070104 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 May 7, 2008, 483 days after receiving the submission on January 10, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K070104 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2007
Decision Date May 07, 2008
Days to Decision 483 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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