Cleared Traditional

K834075 - MAGNESIUM B TEST

K834075 is the FDA 510(k) clearance for MAGNESIUM B TEST by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K834075 · Wako Chemicals USA, Inc. · Chemistry device
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Feb 1984
Decision
70d
Days
Class 1
Risk

K834075 is an FDA 510(k) clearance for the MAGNESIUM B TEST. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K834075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date February 03, 1984
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JGJ Photometric Method, Magnesium

All 64
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K834075.
MAGNESIUM ASSAY KIT
K843031 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
DETERMINATION OF MAGNESIUM IN SERUM OR
K841259 · Sigma Chemical Co. · May 1984
PARAMAX MAGNESIUM REAGENT
K840784 · American Dade · Apr 1984
GIL CHEM MAGNESIUM REAGENT
K820976 · Gilford Diagnostics · Apr 1982
MAGNESIUM TEST KIT
K803088 · Mallinckrodt Critical Care · Jan 1981
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
K802091 · American Monitor Corp. · Oct 1980