Cleared Traditional

TECHNICON RA-100 SYSTEM POTASSIUM

K883586 · Technicon Instruments Corp. · Chemistry
Nov 1988
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K883586 is an FDA 510(k) clearance for the TECHNICON RA-100 SYSTEM POTASSIUM, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on November 29, 1988, 98 days after receiving the submission on August 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K883586 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1988
Decision Date November 29, 1988
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEJ — Tetraphenyl Borate, Colorimetry, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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