ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET— 510(k) K060133

Substantially Equivalent

Inverness Medical Innovations, Inc.

FDA 510(k) clearance K060133 for ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET, Substantially Equivalent on 2006-02-16. Applicant: Inverness Medical Innovations, Inc..

Clearance details

Applicant: Inverness Medical Innovations, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2006-01-18
Decision date: 2006-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.