Cleared Traditional

K883104 - CHEM 1 UIBC (IRON BINDING CAPACITY TEST)

K883104 is an FDA 510(k) clearance for CHEM 1 UIBC (IRON BINDING CAPACITY TEST), manufactured by Technicon Instruments Corp.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K883104

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.

JMO Device Classification - Class 1, General Controls

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 45
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K883104.
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
J&S IRON SATURATING REAGENTS
K893662 · J.S. Medical Assoc. · Jul 1989
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