Cleared Traditional

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM

K970248 · Canyon Diagnostics, Inc. · Chemistry

Feb 1997

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K970248 is an FDA 510(k) clearance for the CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM, a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I — General Controls, product code JQE), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on February 11, 1997, 20 days after receiving the submission on January 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number	K970248 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	JQE — Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1415