Cleared Traditional

K970248 - CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM

K970248 is an FDA 510(k) clearance for CANTROL SERUM IRON AND TOTAL IRON BINDI..., manufactured by Canyon Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JQE cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K970248 · Canyon Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
20d
Days
Class 1
Risk

K970248 is an FDA 510(k) clearance for the CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM. Classified as Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (product code JQE), Class I - General Controls.

Submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 20 days - a notably fast clearance cycle.

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: 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 Canyon Diagnostics, Inc. devices

FDA 510(k) Submission Details - K970248

510(k) Number K970248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1997
Decision Date February 11, 1997
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

JQE Device Classification - Class 1, General Controls

Product Code JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, 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 - JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

Devices cleared under the same product code (JQE) and FDA review panel - the closest regulatory comparables to K970248.
KODAK EKTACHEM DT SLIDES (FE)
K934358 · Eastman Kodak Company · Mar 1994
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K910672 · J.S. Medical Assoc. · Apr 1991
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K884649 · Sclavo, Inc. · Dec 1988
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K842019 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984