Cleared Traditional

HI CHEM ELECTROLYTE BUFFER

K925612 · Hichem Diagnostics · Chemistry
Apr 1993
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K925612 is an FDA 510(k) clearance for the HI CHEM ELECTROLYTE BUFFER, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993, 166 days after receiving the submission on November 5, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K925612 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1992
Decision Date April 20, 1993
Days to Decision 166 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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