ADVIA Centaur Calcitonin (CALCT) assay— 510(k) K182012

Substantially Equivalent

Axis-Shield Diagnostics Limited

FDA 510(k) clearance K182012 for ADVIA Centaur Calcitonin (CALCT) assay, Substantially Equivalent on 2018-12-21. Applicant: Axis-Shield Diagnostics Limited.

Clearance details

Applicant: Axis-Shield Diagnostics Limited
Product code: Code JKR
Advisory panel: Clinical Chemistry
Date received: 2018-07-27
Decision date: 2018-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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