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FDA 510(k)

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

K-Number: K071587 · 2007-07-30

ApplicantInverness Medical Innovations, Inc.
Decision Date2007-07-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical Innovations, Inc.. It received FDA 510(k) clearance on 2007-07-30 under 510(k) number K071587. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY is a medical device that received FDA 510(k) clearance on 2007-07-30. The listed applicant is Inverness Medical Innovations, Inc.. The 510(k) number is K071587.

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

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY received FDA 510(k) clearance on 2007-07-30, under 510(k) number K071587.

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

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

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

The FDA product code for ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY is JJX.

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Other records listing Inverness Medical Innovations, Inc. as applicant

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.

K071265SMARTCHECK INR SYSTEMK060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SETK053196ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)K011479ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMK011616INDUO BLOOD GLUCOSE METER

Related Devices (Code: JJX)

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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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