Cleared Traditional

K811942 - J & S IRON SATURATING REAGENT

K811942 is an FDA 510(k) clearance for J & S IRON SATURATING REAGENT, manufactured by Thyroid Diagnostics, Inc.. The device is a Class 1 Toxicology device with product code JQF cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K811942 · Thyroid Diagnostics, Inc. · Toxicology device
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Sep 1981
Decision
63d
Days
Class 1
Risk

K811942 is an FDA 510(k) clearance for the J & S IRON SATURATING REAGENT. Classified as Bathophenanthroline, Iron Binding Capacity (product code JQF), Class I - General Controls.

Submitted by Thyroid Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1415 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thyroid Diagnostics, Inc. devices

FDA 510(k) Submission Details - K811942

510(k) Number K811942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1981
Decision Date September 08, 1981
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

JQF Device Classification - Class 1, General Controls

Product Code JQF Bathophenanthroline, 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 - JQF Bathophenanthroline, Iron Binding Capacity

All 7
Devices cleared under the same product code (JQF) and FDA review panel - the closest regulatory comparables to K811942.
WAKO(TM) UIBC
K875176 · Wako Chemicals USA, Inc. · Feb 1988
TRANSFERMETER
K863066 · J. D. Assoc. · Dec 1986
TOTAL IRON BINDING CAPACITY TEST
K830032 · Sclavo, Inc. · Jan 1983
IRON & TICB
K810086 · Bio-Analytics Laboratories, Inc. · Jan 1981
ELVI TOTAL IRON BINDING CAPACITY
K792409 · Volu Sol Medical Industries · Dec 1979