Cleared Traditional

TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD

K895672 · Technicon Instruments Corp. · Chemistry
Oct 1989
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K895672 is an FDA 510(k) clearance for the TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on October 25, 1989, 35 days after receiving the submission on September 20, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K895672 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1989
Decision Date October 25, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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