Cleared Traditional

KING DIAGNOSTICS MAGNESIUM REAGENT

K923927 · King Diagnostics, Inc. · Chemistry
Sep 1992
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K923927 is an FDA 510(k) clearance for the KING DIAGNOSTICS MAGNESIUM REAGENT, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 30, 1992, 56 days after receiving the submission on August 5, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K923927 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1992
Decision Date September 30, 1992
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGJ — Photometric Method, Magnesium
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1495

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