ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)— 510(k) K053196

Name: FDA 510(k) clearance K053196
Creator: U.S. Food and Drug Administration
Published: 2005-12-16

Substantially Equivalent

Inverness Medical Innovations, Inc.

FDA 510(k) clearance K053196 for ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST), Substantially Equivalent on 2005-12-16. Applicant: Inverness Medical Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Inverness Medical Innovations, Inc.
Product code: Code NJV
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2005-11-16
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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