Cleared Traditional

TECHNICON ASSIST POTASSIUM

K883585 · Technicon Instruments Corp. · Chemistry
Nov 1988
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K883585 is an FDA 510(k) clearance for the TECHNICON ASSIST 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 K883585 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

Similar Devices — CEJ Tetraphenyl Borate, Colorimetry, Potassium

All 15
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
K043267 · Randox Laboratories, Ltd. · Feb 2005
POTASSIUM QVET
K943026 · Prisma Systems · Dec 1994
REFLOTRON POTASSIUM TEST TABS
K904033 · Boehringer Mannheim Corp. · Nov 1990
POTASSIUM REAGENT SET
K902574 · Tech-Co, Inc. · Jul 1990
TECHNICON RA-100 SYSTEM POTASSIUM
K883586 · Technicon Instruments Corp. · Nov 1988
IQ POTASSIUM
K881440 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1988