Cleared Traditional

K883104 - CHEM 1 UIBC (IRON BINDING CAPACITY TEST)

K883104 is the FDA 510(k) clearance for CHEM 1 UIBC (IRON BINDING CAPACITY TEST) by Technicon Instruments Corp.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K883104 · Technicon Instruments Corp. · Chemistry device
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Oct 1988
Decision
92d
Days
Class 1
Risk

K883104 is an FDA 510(k) clearance for the CHEM 1 UIBC (IRON BINDING CAPACITY TEST). Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 92 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K883104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1988
Decision Date October 25, 1988
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K883104.
BIOTROL UIBC REAGENT
K912795 · Biotrol, USA, Inc. · Aug 1991
IRON 5 X CONC REAGENT
K904116 · Trace Scientific , Ltd. · Sep 1990
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · American Research Products Co. · May 1990
UNSATURATED IRON BINDING CAPACITY
K881761 · Data Medical Associates, Inc. · Jul 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546 · Boehringer Mannheim Corp. · Mar 1988
IRON REAGENT
K874055 · Trace Scientific , Ltd. · Oct 1987