Cleared Traditional

K821102 - MEGNESIUM REAGENT KIT
(FDA 510(k) Clearance)

May 1982
Decision
15d
Days
Class 1
Risk

K821102 is an FDA 510(k) clearance for the MEGNESIUM REAGENT KIT. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).

Submitted by Anco Medical Reagents & Assoc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982, 15 days after receiving the submission on April 20, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.

Submission Details

510(k) Number K821102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 05, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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

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