CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM— 510(k) K970248

Name: FDA 510(k) clearance K970248
Creator: U.S. Food and Drug Administration
Published: 1997-02-11

Substantially Equivalent

Canyon Diagnostics, Inc.

FDA 510(k) clearance K970248 for CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM, Substantially Equivalent on 1997-02-11. Applicant: Canyon Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Canyon Diagnostics, Inc.
Product code: Code JQE
Device class: Class 1
Regulation: 21 CFR 862.1415
Advisory panel: Clinical Chemistry
Date received: 1997-01-22
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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