Cleared Traditional

K873530 - PARAMAX MAGNESIUM REAGENT

K873530 is an FDA 510(k) clearance for PARAMAX MAGNESIUM REAGENT, manufactured by Baxter Healthcare Corp. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K873530 · Baxter Healthcare Corp · Chemistry device
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Dec 1987
Decision
104d
Days
Class 1
Risk

K873530 is an FDA 510(k) clearance for the PARAMAX MAGNESIUM REAGENT. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 104 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K873530

510(k) Number K873530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date December 14, 1987
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 K873530.
MULTICHEM (R) MAGNESIUM REAGENT
K874595 · Simmler, Inc. · Jan 1988
RAICHEM(TM) MAGNESIUM REAGENT
K874822 · Reagents Applications, Inc. · Jan 1988
MAGNESIUM
K874847 · Tech-Co, Inc. · Dec 1987
BIOTROL MAGNESIUM CALMAGITE
K873180 · Biotrol, USA, Inc. · Sep 1987
MAGNESIUM REAGENT - CALMAGITE METHOD
K870370 · Trace Scientific , Ltd. · Aug 1987
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · Abbott Laboratories · Jul 1987