Cleared Traditional

IQ POTASSIUM

K881440 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry
May 1988
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K881440 is an FDA 510(k) clearance for the IQ POTASSIUM, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 27, 1988, 52 days after receiving the submission on April 5, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K881440 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1988
Decision Date May 27, 1988
Days to Decision 52 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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