Cleared Traditional

K800327 - MAGNESIUM REAGENT

K800327 is the FDA 510(k) clearance for MAGNESIUM REAGENT by Alta Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JGJ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K800327 · Alta Diagnostics, Inc. · Chemistry device
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Mar 1980
Decision
42d
Days
Class 1
Risk

K800327 is an FDA 510(k) clearance for the MAGNESIUM REAGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 42 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 Alta Diagnostics, Inc. devices

Submission Details

510(k) Number K800327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1980
Decision Date March 25, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 67
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K800327.
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