Cleared Traditional

K771469 - MULTISTAT III MAGNESIUM TEST (FDA 510(k) Clearance)

Sep 1977
Decision
39d
Days
Class 1
Risk

K771469 is an FDA 510(k) clearance for the MULTISTAT III MAGNESIUM TEST. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977, 39 days after receiving the submission on August 4, 1977.

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

Submission Details

510(k) Number K771469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date September 12, 1977
Days to Decision 39 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