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FDA 510(k)

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM

K-Number: K970248 · 1997-02-11

ApplicantCanyon Diagnostics, Inc.
Decision Date1997-02-11
Product CodeJQE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K970248. The device is classified under product code JQE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM?

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Canyon Diagnostics, Inc.. The 510(k) number is K970248.

When did CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM receive FDA 510(k) clearance?

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM received FDA 510(k) clearance on 1997-02-11, under 510(k) number K970248.

Who is the listed applicant for CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM?

The FDA 510(k) record lists Canyon Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM?

The FDA product code for CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM is JQE.

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Other records listing Canyon Diagnostics, Inc. as applicant

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Related Devices (Code: JQE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934358KODAK EKTACHEM DT SLIDES (FE)Eastman Kodak CompanyK910672J&S PEDIATRIC IRON SATURATING REAGENTJ.S. Medical Assoc.K884649TOTAL IRON BINDING CAPACITY TESTSclavo, Inc.K864548ALFERR TIBC TUBEBenchmark ReagentsK842019TIBC PRETREATMENT KITE.I. Dupont DE Nemours & Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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