FDA 510(k)

DART IRON & IRON BINDING CAPACITY REAGENT

K-Number: K854305 · 1985-11-12

Decision Date1985-11-12

Product CodeCFM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DART IRON & IRON BINDING CAPACITY REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K854305. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DART IRON & IRON BINDING CAPACITY REAGENT?

DART IRON & IRON BINDING CAPACITY REAGENT is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K854305.

When did DART IRON & IRON BINDING CAPACITY REAGENT receive FDA 510(k) clearance?

DART IRON & IRON BINDING CAPACITY REAGENT received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854305.

Who is the listed applicant for DART IRON & IRON BINDING CAPACITY REAGENT?

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

What is the FDA product code for DART IRON & IRON BINDING CAPACITY REAGENT?

The FDA product code for DART IRON & IRON BINDING CAPACITY REAGENT is CFM.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: CFM)

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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.