Cleared Traditional

K880880 - RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC

K880880 is an FDA 510(k) clearance for RAICHEM(TM) MAGNESIUM REAGENT, manufactured by Reagents Applications, Inc.. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K880880 · Reagents Applications, Inc. · Chemistry device
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May 1988
Decision
86d
Days
Class 1
Risk

K880880 is an FDA 510(k) clearance for the RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 86 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 Reagents Applications, Inc. devices

FDA 510(k) Submission Details - K880880

510(k) Number K880880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date May 27, 1988
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
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 K880880.
MAGNESIUM REAGENT (MAGON SULFONATE)
K883972 · Sigma Chemical Co. · Nov 1988
TECHNICON RA(TM) SYSTEMS - MAGNESIUM
K883326 · Technicon Instruments Corp. · Oct 1988
MAGNESIUM REAGENT SET
K882256 · Tech-Neal Scientific, Inc. · Aug 1988
MAGNESIUM LIQUID STABLE REAGENT SET
K881300 · Medical Analysis Systems, Inc. · May 1988
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)
K874506 · Technicon Instruments Corp. · Jan 1988
KODAK EKTACHEM DT SLIDES (MG)
K874576 · Eastman Kodak Company · Jan 1988