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

Name: FDA 510(k) clearance K182012
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

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. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics Limited
Product code: Code JKR
Device class: Class 2
Regulation: 21 CFR 862.1140
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 ↗

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K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 32013-12-04
K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)2006-08-30
K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL2002-12-09
K990073 — CALCITONIN1999-05-11

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