Cleared Traditional

K852005 - MG REAGENT

K852005 is an FDA 510(k) clearance for MG REAGENT, manufactured by Alpkem Corp.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K852005 · Alpkem Corp. · Chemistry device
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Jun 1985
Decision
49d
Days
Class 1
Risk

K852005 is an FDA 510(k) clearance for the MG REAGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 49 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 Alpkem Corp. devices

FDA 510(k) Submission Details - K852005

510(k) Number K852005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date June 25, 1985
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 85
Devices cleared under the same product code (JGJ) and FDA review panel - the closest regulatory comparables to K852005.
MAGNESIUM REAGENT SET
K860215 · Sterling Diagnostics, Inc. · Feb 1986
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC
K853853 · Technicon Instruments Corp. · Oct 1985
MAGNESIUM
K853592 · Pointe Scientific, Inc., · Sep 1985
DEMAND MAGNESIUM
K851657 · Cooper Biomedical, Inc. · May 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
K850381 · Advanced Biomedical Methods, Inc. · Mar 1985
DATA-CHEM MAGNESIUM
K844278 · Data Medical Associates, Inc. · Jan 1985