Cleared Traditional

K861386 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)

K861386 is an FDA 510(k) clearance for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE..., manufactured by Eastman Kodak Company. The device is a Class 1 Chemistry device with product code JGJ cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K861386 · Eastman Kodak Company · Chemistry device
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Aug 1986
Decision
134d
Days
Class 1
Risk

K861386 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG). Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 26, 1986 after a review of 134 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K861386

510(k) Number K861386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date August 26, 1986
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
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 K861386.
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
K872311 · Abbott Laboratories · Jul 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · Em Diagnostic Systems, Inc. · Mar 1987
MAGNESIOMETER
K863069 · J. D. Assoc. · Dec 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · Em Diagnostic Systems, Inc. · Aug 1986
MAGNESIUM PROCEDURE
K861668 · Data Medical Associates, Inc. · May 1986
MAGNESIUM REAGENT SET
K855190 · Technostics Intl. · Feb 1986