Cleared Traditional

K964915 - MAGNESIUM

K964915 is an FDA 510(k) clearance for MAGNESIUM, manufactured by Derma Media Lab., Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K964915 · Derma Media Lab., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
107d
Days
Class 1
Risk

K964915 is an FDA 510(k) clearance for the MAGNESIUM. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on March 26, 1997 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K964915

510(k) Number K964915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date March 26, 1997
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

JGJ Device Classification - Class 1, General Controls

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 83
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K964915.
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · Boehringer Mannheim Corp. · Oct 1998
MG
K981192 · Abbott Laboratories · May 1998
RANDOX MAGNESIUM
K974606 · Randox Laboratories, Ltd. · Feb 1998
MAGNESIUM REAGENT
K952426 · Schiapparelli Biosystems, Inc. · Aug 1995
MAGNESIUM QVET
K943001 · Prisma Systems · Dec 1994
OLYMPUS MAGNESIUM REAGENT
K944407 · Olympus America, Inc. · Dec 1994