Cleared Traditional

K943001 - MAGNESIUM QVET

K943001 is an FDA 510(k) clearance for MAGNESIUM QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K943001 · Prisma Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
189d
Days
Class 1
Risk

K943001 is an FDA 510(k) clearance for the MAGNESIUM QVET. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 189 days - an extended review 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: 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 Prisma Systems devices

FDA 510(k) Submission Details - K943001

510(k) Number K943001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 29, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
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 67
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K943001.
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
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MG
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RANDOX MAGNESIUM
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OLYMPUS MAGNESIUM REAGENT
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ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED
K944202 · Abbott Laboratories · Nov 1994
EMDS MAGNESIUM (MG) TEST
K935183 · Em Diagnostic Systems, Inc. · Dec 1993