Cleared Traditional

TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)

K896829 · Technicon Instruments Corp. · Chemistry
Feb 1990
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K896829 is an FDA 510(k) clearance for the TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD), a Flame Photometry, Sodium (Class II — Special Controls, product code JGT), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on February 23, 1990, 81 days after receiving the submission on December 4, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K896829 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1989
Decision Date February 23, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JGT — Flame Photometry, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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