Cleared Traditional

K933329 - KING DIAGNOSTICS IRON AND TOTAL IRON BI...

K933329 is the FDA 510(k) clearance for KING DIAGNOSTICS IRON AND TOTAL IRON BI... by King Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K933329 · King Diagnostics, Inc. · Chemistry device
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Oct 1993
Decision
106d
Days
Class 1
Risk

K933329 is an FDA 510(k) clearance for the KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 King Diagnostics, Inc. devices

Submission Details

510(k) Number K933329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1993
Decision Date October 22, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMO Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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 - JMO Ferrozine (colorimetric) Iron Binding Capacity

All 33
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K933329.
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139 · Olympus America, Inc. · Feb 1996
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE
K946354 · Data Medical Associates, Inc. · May 1995
IRON/UIBC REAGENT
K932517 · Sigma Diagnostics, Inc. · Nov 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569 · Baxter Diagnostics, Inc. · Aug 1992
SYNERMED UIBC REAGENT KIT
K922784 · Synermed, Inc. · Jul 1992