Cleared Traditional

K912717 - J&S UIBC REAGENTS

K912717 is the FDA 510(k) clearance for J&S UIBC REAGENTS by J.S. Medical Assoc.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K912717 · J.S. Medical Assoc. · Chemistry device
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Sep 1991
Decision
99d
Days
Class 1
Risk

K912717 is an FDA 510(k) clearance for the J&S UIBC REAGENTS. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 99 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 J.S. Medical Assoc. devices

Submission Details

510(k) Number K912717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date September 25, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 34
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K912717.
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
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · Em Diagnostic Systems, Inc. · Sep 1991
BIOTROL UIBC REAGENT
K912795 · Biotrol, USA, Inc. · Aug 1991
IRON 5 X CONC REAGENT
K904116 · Trace Scientific , Ltd. · Sep 1990