Cleared Traditional

TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD

K895664 · Technicon Instruments Corp. · Chemistry
Nov 1989
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K895664 is an FDA 510(k) clearance for the TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on November 14, 1989, 55 days after receiving the submission on September 20, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K895664 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1989
Decision Date November 14, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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