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FDA 510(k)

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

K-Number: K060133 · 2006-02-16

ApplicantInverness Medical Innovations, Inc.
Decision Date2006-02-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET 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 2006-02-16 under 510(k) number K060133. 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) ASSAY VERIFICATION SET?

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET is a medical device that received FDA 510(k) clearance on 2006-02-16. The listed applicant is Inverness Medical Innovations, Inc.. The 510(k) number is K060133.

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

ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET received FDA 510(k) clearance on 2006-02-16, under 510(k) number K060133.

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

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) ASSAY VERIFICATION SET?

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

Related Clinical Trials

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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 SYSTEMK071587ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAYK053196ISCHEMIA 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)

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.

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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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