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FDA 510(k)

ALBUMIN COBALT BINDING TEST (ACB TEST)

K-Number: K023824 · 2003-02-14

ApplicantIschemia Technologies, Inc.
Decision Date2003-02-14
Product CodeNJV
Advisory CommitteeCH
DecisionUnknown

Device Summary

ALBUMIN COBALT BINDING TEST (ACB TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Ischemia Technologies, Inc.. It received FDA 510(k) clearance on 2003-02-14 under 510(k) number K023824. The device is classified under product code NJV. It was reviewed by the CH advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ALBUMIN COBALT BINDING TEST (ACB TEST)?

ALBUMIN COBALT BINDING TEST (ACB TEST) is a medical device that received FDA 510(k) clearance on 2003-02-14. The listed applicant is Ischemia Technologies, Inc.. The 510(k) number is K023824.

When did ALBUMIN COBALT BINDING TEST (ACB TEST) receive FDA 510(k) clearance?

ALBUMIN COBALT BINDING TEST (ACB TEST) received FDA 510(k) clearance on 2003-02-14, under 510(k) number K023824.

Who is the listed applicant for ALBUMIN COBALT BINDING TEST (ACB TEST)?

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

What is the FDA product code for ALBUMIN COBALT BINDING TEST (ACB TEST)?

The FDA product code for ALBUMIN COBALT BINDING TEST (ACB TEST) is NJV.

Related Clinical Trials

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Related Devices (Code: NJV)

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.

K053196ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)Inverness Medical Innovations, Inc.

Official Source

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

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