Cleared Traditional

K912717 - J&S UIBC REAGENTS

K912717 is an FDA 510(k) clearance for J&S UIBC REAGENTS, manufactured by J.S. Medical Assoc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K912717

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 K912717.
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569 · Baxter Diagnostics, Inc. · Aug 1992
SYNERMED UIBC REAGENT KIT
K922784 · Synermed, Inc. · Jul 1992
J&S IRON REAGENTS
K912716 · J.S. Medical Assoc. · Sep 1991
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